Asymmetric Hearing Loss in Adult Cochlear Implant Recipients: Results and Recommendations From a Multisite Prospective Clinical Trial.

OBJECTIVE: A multisite clinical trial was conducted to obtain cochlear implant (CI) efficacy data in adults with asymmetric hearing loss (AHL) and establish an evidence-based framework for clinical decision-making regarding CI candidacy, counseling, and assessment tools. Study hypotheses were threefold: (1) 6-month postimplant performance in the poor ear (PE) with a CI will be significantly better than preimplant performance with a hearing aid (HA), (2) 6-month postimplant performance with a CI and HA (bimodal) will be significantly better than preimplant performance with bilateral HAs (Bil HAs), and (3) 6-month postimplant bimodal performance will be significantly better than aided, better ear (BE) performance. DESIGN: Forty adults with AHL from four, metropolitan CI centers participated. Hearing criteria for the ear to be implanted included (1) pure-tone average (PTA, 0.5, 1, 2 kHz) of >70 dB HL, (2) aided, monosyllabic word score of ≤30%, (3) duration of severe-to-profound hearing loss of ≥6 months, and (4) onset of hearing loss ≥6 years of age. Hearing criteria for the BE included (1) PTA (0.5, 1, 2, 4 kHz) of 40 to 70 dB HL, (2) currently using a HA, (3) aided, word score of >40%, and (4) stable hearing for the previous 1-year period. Speech perception and localization measures, in quiet and in noise, were administered preimplant and at 3-, 6-, 9-, and 12-months postimplant. Preimplant testing was performed in three listening conditions, PE HA, BE HA, and Bil HAs. Postimplant testing was performed in three conditions, CI, BE HA, and bimodal. Outcome factors included age at implantation and length of deafness (LOD) in the PE. RESULTS: A hierarchical nonlinear analysis predicted significant improvement in the PE by 3 months postimplant versus preimplant for audibility and speech perception with a plateau in performance at approximately 6 months. The model predicted significant improvement in postimplant, bimodal outcomes versus preimplant outcomes (Bil HAs) for all speech perception measures by 3 months. Both age and LOD were predicted to moderate some CI and bimodal outcomes. In contrast with speech perception, localization in quiet and noise was not predicted to improve by 6 months when comparing Bil HAs (preimplant) to bimodal (postimplant) outcomes. However, when participants' preimplant everyday listening condition (BE HA or Bil HAs) was compared with bimodal performance, the model predicted significant improvement by 3 months for localization in quiet and noise. Lastly, BE HA results were stable over time; a generalized linear model analysis revealed bimodal performance was significantly better than performance with a BE HA at all postimplant intervals for most speech perception measures and localization. CONCLUSIONS: Results revealed significant CI and bimodal benefit for AHL participants by 3-months postimplant, with a plateau in CI and bimodal performance at approximately 6-months postimplant. Results can be used to inform AHL CI candidates and to monitor postimplant performance. On the basis of this and other AHL research, clinicians should consider a CI for individuals with AHL if the PE has a PTA (0.5, 1, 2 kHz) >70 dB HL and a Consonant-Vowel Nucleus-Consonant word score ≤40%. LOD >10 years should not be a contraindication.

Evaluation of the American English Matrix Test with Cochlear Implant Recipients.

OBJECTIVE: Currently, the variety of speech recognition tests used to evaluate cochlear implant (CI) recipients makes it difficult to compare results, especially across languages. The Matrix Test limits contextual cues and is available in multiple languages, including American English. The current study investigated test format and noise type for the American English Matrix Test (AMT) and compared results to AzBio sentence scores in adult CI recipients. DESIGN: Fifteen experienced CI recipients were administered the AMT in fixed- and adaptive-level formats and AzBio sentences in a fixed-level format. Testing in noise used the AMT-specific noise and 4-talker babble. RESULTS: Ceiling effects were present for all AMT fixed-level conditions and AzBio sentences in quiet. Group mean AzBio scores were poorer than AMT scores. Noise type affected performance regardless of format; 4-talker babble was more challenging. CONCLUSIONS: The limited number of word choices in each category likely aided listeners performance for the AMT compared to AzBio sentences. The use of the AMT in the designed adaptive-level format would allow effective evaluation and comparison of CI performance internationally. A test battery with the AMT may also benefit from including AzBio sentences in 4-talker babble to reflect performance during listening challenges.

Relationship between electrode position and temporal modulation sensitivity in cochlear implant users: Are close electrodes always better?

Temporal modulation sensitivity has been studied extensively for cochlear implant (CI) users due to its strong correlation to speech recognition outcomes. Previous studies reported that temporal modulation detection thresholds (MDTs) vary across the tonotopic axis and attributed this variation to patchy neural survival. However, correlates of neural health identified in animal models depend on electrode position in humans. Nonetheless, the relationship between MDT and electrode location has not been explored. We tested 13 ears for the effect of distance on modulation sensitivity, specifically targeting the question of whether electrodes closer to the modiolus are universally beneficial. Participants in this study were postlingually deafened and users of Cochlear Nucleus CIs. The distance of each electrode from the medial wall (MW) of the cochlea and mid-modiolar axis (MMA) was measured from scans obtained using computerized tomography (CT) imaging. The distance measures were correlated with slopes of spatial tuning curves measured on selected electrodes to investigate if electrode position accounts, at least in part, for the width of neural excitation. In accordance with previous findings, electrode position explained 24% of the variance in slopes of the spatial tuning curves. All functioning electrodes were also measured for MDTs. Five ears showed a positive correlation between MDTs and at least one distance measure across the array; 6 ears showed negative correlations and the remaining two ears showed no relationship. The ears showing positive MDT-distance correlations, thus benefiting from electrodes being close to the neural elements, were those who performed better on the two speech recognition measures, i.e., speech reception thresholds (SRTs) and recognition of the AzBio sentences. These results could suggest that ears able to take advantage of the proximal placement of electrodes are likely to have better speech recognition outcomes. Previous histological studies of humans demonstrated that speech recognition is correlated with spiral ganglion cell counts. Alternatively, ears with good speech recognition outcomes may have good overall neural health, which is a precondition for close electrodes to produce spatially confined neural excitation patterns that facilitate modulation sensitivity. These findings suggest that the methods to reduce channel interaction, e.g., perimodiolar electrode array or current focusing, may only be beneficial for a subgroup of CI users. Additionally, it suggests that estimating neural survival preoperatively is important for choosing the most appropriate electrode array type (perimodiolar vs. lateral wall) for optimal implant function.

The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) study: International consensus on outcome measures for trials of interventions for adults with single-sided deafness.

BACKGROUND: Single-sided deafness (SSD) has functional, psychological, and social consequences. Interventions for adults with SSD include hearing aids and auditory implants. Benefits and harms (outcome domains) of these interventions are until now reported inconsistently in clinical trials. Inconsistency in reporting outcome measures prevents meaningful comparisons or syntheses of trial results. The Core Rehabilitation Outcome Set for Single-Sided Deafness (CROSSSD) international initiative used structured communication techniques to achieve consensus among healthcare users and professionals working in the field of SSD. The novel contribution is a set of core outcome domains that experts agree are critically important to assess in all clinical trials of SSD interventions. METHODS: A long list of candidate outcome domains compiled from a systematic review and published qualitative data, informed the content of a two-round online Delphi survey. Overall, 308 participants from 29 countries were enrolled. Of those, 233 participants completed both rounds of the survey and scored each outcome domain on a 9-point scale. The set of core outcome domains was finalised via a web-based consensus meeting with 12 participants. Votes involved all stakeholder groups, with an approximate 2:1 ratio of professionals to healthcare users participating in the Delphi survey, and a 1:1 ratio participating in the consensus meeting. RESULTS: The first round of the survey listed 44 potential outcome domains, organised thematically. A further five outcome domains were included in Round 2 based on participant feedback. The structured voting at round 2 identified 17 candidate outcome domains which were voted on at the consensus meeting. Consensus was reached for a core outcome domain set including three outcome domains: spatial orientation, group conversations in noisy social situations, and impact on social situations. Seventy-seven percent of the remaining Delphi participants agreed with this core outcome domain set. CONCLUSIONS: Adoption of the internationally agreed core outcome domain set would promote consistent assessment and reporting of outcomes that are meaningful and important to all relevant stakeholders. This consistency will in turn enable comparison of outcomes reported across clinical trials comparing SSD interventions in adults and reduce research waste. Further research will determine how those outcome domains should best be measured.

External Validation of Cochlear Implant Screening Tools Demonstrates Modest Generalizability.

OBJECTIVE: To assess the clinical application of five recently published cochlear implant (CI) candidacy evaluation (CICE) referral screening tools through external validation. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary otology/neurotology practice. PATIENTS: Adults who underwent CICE between December 2020 and September 2021. INTERVENTIONS: CICE referral screening tools versus CI candidacy criteria. MAIN OUTCOME MEASURES: CICE screening tool performance, based on the ability to identify patients who met the CI candidacy criteria, was evaluated. CI candidacy criteria were defined as best-aided AzBio sentences at +10 signal-to-noise ratio and either 60% or less accuracy to reflect traditional criteria used in clinical settings or 40% or less accuracy (only patients 65 years or older) to reflect Medicare-eligible criteria. RESULTS: Screening criteria of proposed CICE referral tools vary widely across pure-tone average and word recognition scores. When screened by traditional criteria, the sensitivities and specificities of these referral tools varied from 40 to 77% and from 22 to 86%, respectively. When screened by Medicare-eligible criteria, sensitivities and specificities varied from 41 to 81% and from 24 to 91%, respectively. The screening tool proposed by Zwolan et al. ( Otol Neurotol 2020;41(7):895-900) demonstrated the best overall performance for traditional (Youden's J , 0.37; sensitivity, 62%; specificity, 75%) and Medicare-eligible patients (Youden's J , 0.44; sensitivity, 66%; specificity, 78%). All screening tools performed worse on the validation cohort compared with their respective development cohorts. CONCLUSIONS: Current tools for determining CICE referral have diverse screening criteria. These combinations of pure-tone average and word recognition score are modestly successful at identifying CI candidates.

American Cochlear Implant Alliance Task Force Guidelines for Clinical Assessment and Management of Adult Cochlear Implantation for Single-Sided Deafness.

The indications for cochlear implantation have expanded to include individuals with profound sensorineural hearing loss in the impaired ear and normal hearing (NH) in the contralateral ear, known as single-sided deafness (SSD). There are additional considerations for the clinical assessment and management of adult cochlear implant candidates and recipients with SSD as compared to conventional cochlear implant candidates with bilateral moderate to profound sensorineural hearing loss. The present report reviews the current evidence relevant to the assessment and management of adults with SSD. A systematic review was also conducted on published studies that investigated outcomes of cochlear implant use on measures of speech recognition in quiet and noise, sound source localization, tinnitus perception, and quality of life for this patient population. Expert consensus and systematic review of the current literature were combined to provide guidance for the clinical assessment and management of adults with SSD.

Prefrontal cortex supports speech perception in listeners with cochlear implants.

Cochlear implants are neuroprosthetic devices that can restore hearing in people with severe to profound hearing loss by electrically stimulating the auditory nerve. Because of physical limitations on the precision of this stimulation, the acoustic information delivered by a cochlear implant does not convey the same level of acoustic detail as that conveyed by normal hearing. As a result, speech understanding in listeners with cochlear implants is typically poorer and more effortful than in listeners with normal hearing. The brain networks supporting speech understanding in listeners with cochlear implants are not well understood, partly due to difficulties obtaining functional neuroimaging data in this population. In the current study, we assessed the brain regions supporting spoken word understanding in adult listeners with right unilateral cochlear implants (n=20) and matched controls (n=18) using high-density diffuse optical tomography (HD-DOT), a quiet and non-invasive imaging modality with spatial resolution comparable to that of functional MRI. We found that while listening to spoken words in quiet, listeners with cochlear implants showed greater activity in the left prefrontal cortex than listeners with normal hearing, specifically in a region engaged in a separate spatial working memory task. These results suggest that listeners with cochlear implants require greater cognitive processing during speech understanding than listeners with normal hearing, supported by compensatory recruitment of the left prefrontal cortex.

Cortical Regions Activated by Spectrally Degraded Speech in Adults With Single Sided Deafness or Bilateral Normal Hearing.

Those with profound sensorineural hearing loss from single sided deafness (SSD) generally experience greater cognitive effort and fatigue in adverse sound environments. We studied cases with right ear, SSD compared to normal hearing (NH) individuals. SSD cases were significantly less correct in naming last words in spectrally degraded 8- and 16-band vocoded sentences, despite high semantic predictability. Group differences were not significant for less intelligible 4-band sentences, irrespective of predictability. SSD also had diminished BOLD percent signal changes to these same sentences in left hemisphere (LH) cortical regions of early auditory, association auditory, inferior frontal, premotor, inferior parietal, dorsolateral prefrontal, posterior cingulate, temporal-parietal-occipital junction, and posterior opercular. Cortical regions with lower amplitude responses in SSD than NH were mostly components of a LH language network, previously noted as concerned with speech recognition. Recorded BOLD signal magnitudes were averages from all vertices within predefined parcels from these cortex regions. Parcels from different regions in SSD showed significantly larger signal magnitudes to sentences of greater intelligibility (e.g., 8- or 16- vs. 4-band) in all except early auditory and posterior cingulate cortex. Significantly lower response magnitudes occurred in SSD than NH in regions prior studies found responsible for phonetics and phonology of speech, cognitive extraction of meaning, controlled retrieval of word meaning, and semantics. The findings suggested reduced activation of a LH fronto-temporo-parietal network in SSD contributed to difficulty processing speech for word meaning and sentence semantics. Effortful listening experienced by SSD might reflect diminished activation to degraded speech in the affected LH language network parcels. SSD showed no compensatory activity in matched right hemisphere parcels.

Assessment of Cochlear Implants for Adult Medicare Beneficiaries Aged 65 Years or Older Who Meet Expanded Indications of Open-Set Sentence Recognition: A Multicenter Nonrandomized Clinical Trial.

Importance: Current indications for Medicare beneficiaries to receive a cochlear implant are outdated. Multichannel cochlear implant systems may be effective when provided to Medicare beneficiaries using expanded indications. Objective: To examine the effectiveness of cochlear implants, as measured by improvement on the AzBio Sentence Test, for newly implanted Medicare beneficiaries who meet the expanded indications of an AzBio Sentence Test score of 41% to 60% in their best-aided condition. Design, Setting, and Participants: A multicenter nonrandomized trial examined preoperative and postoperative speech recognition, telephone communication, hearing device benefit, health utility, and quality of life for 34 participants enrolled at 8 different centers who received a cochlear implant between September 17, 2014, and July 10, 2018. All participants were 65 years or older, had bilateral moderate to profound hearing loss, and had a best-aided preoperative AzBio Sentence Test score in quiet of 41% to 60%. Analysis was performed on an intention-to-treat basis. Statistical analysis of final results took place from July 29 to October 1, 2019. Intervention: Multichannel cochlear implants. Main Outcomes and Measures: The study examined the a priori hypothesis that the cochlear implant would improve the AzBio Sentence Test score in the best-aided condition by 25% or more and in the implanted ear-alone condition by 30% or more. The study additionally examined word and telephone recognition and examined device benefit, health utility, and quality of life. Results: A total of 34 participants received a cochlear implant; 31 (23 men [74%]; median age, 73.6 years [range, 65.7-85.1 years]) completed testing through the 6-month evaluation, and 29 completed testing through the 12-month evaluation. Median preoperative AzBio Sentence Test scores were 53% (range, 26%-60%) for the best-aided condition and 24% (range, 0%-53%) for the cochlear implant-alone condition; median scores 12 months after implantation improved to 89% (range, 36%-100%) for the best-aided condition and 77% (range, 13%-100%) for the cochlear implant-alone condition. This outcome represents a median change of 36% (range, -22% to 75%) for the best-aided condition (lower bound of 1-sided 95% CI, 31%) and a median change of 53% (range, -15% to 93%) for the cochlear implant-alone condition (lower bound of 1-sided 95% CI, 45%). Conclusions and Relevance: Intervention with a cochlear implant was associated with improved sentence, word, and telephone recognition in adult Medicare beneficiaries whose preoperative AzBio Sentence Test scores were between 41% and 60%. These findings support expansion of the Center for Medicare & Medicaid current indications for cochlear implants. Trial Registration: ClinicalTrials.gov Identifier: NCT02075229.

Hearing and Quality-of-Life Outcomes After Cochlear Implantation in Adult Hearing Aid Users 65 Years or Older: A Secondary Analysis of a Nonrandomized Clinical Trial.

Importance: Hearing loss, especially moderate to severe forms, has the potential to negatively affect an individual's physical, social, emotional, and cognitive well-being. Moreover, having ineffective binaural hearing increases difficulty understanding speech in noise and leads to a greater degree of social isolation and loneliness and a reduced quality of life (QoL). Objective: To explore the audiometric and holistic effects of cochlear implantation in a group of adults 65 years or older compared with an optimized bilateral hearing aid condition. Design, Setting, and Participants: This ad hoc secondary analysis of a prospective, single-subject, repeated-measures nonrandomized clinical trial included 13 cochlear implantation centers across the United States. Participants 65 years or older with postlingual bilateral moderate-to-profound sensorineural hearing loss with aided Consonant-Vowel Nucleus-Consonant (CNC) word scores in quiet of 40% or less in the ear to undergo implantation and 50% or less in the contralateral ear were included in the analysis. Baseline QoL testing was performed after 1 month of optimized bilateral hearing aid use. Participants were enrolled from February 20, 2017, to May 3, 2018, and follow-up was completed December 21, 2018. Data were analyzed from March 25, 2019, to March 31, 2020. Interventions: Unilateral implantation with a slim, modiolar cochlear implant device. Hearing aid use in the contralateral ear was required through the 6-month primary end-point interval. Main Outcomes and Measures: The primary objective was to evaluate speech perception before and 6 months after activation of a new cochlear implant. Secondary objectives were QoL metrics in the everyday listening condition before and 6 months after implantation. Results: Seventy participants (51 men [73%]) with a median age of 74 (range, 65-91) years were included in the analysis. No major adverse events occurred. Mixed-model analysis with estimated marginal means and 95% CIs compared preimplantation baseline performance with 6-month postimplantation performance. A clinically important improvement in CNC words was shown in the bimodal condition, with a mean difference of 37.2% (95% CI, 32.0%-42.4%), and in the unilateral (cochlear implant only) condition, with a mean difference of 44.1% (95% CI, 39.0%-49.2%). A clinically important improvement in noise (AzBio sentences signal-to-noise ratio of +10 dB) was also shown, with a mean difference of 21.6% (95% CI, 15.7%-27.5%) in the bimodal condition and 24.5% (95% CI, 18.3%-30.7%) in the unilateral condition. The Health Utilities Index Mark 3 multiple-attribute score improved by 0.186 (95% CI, 0.136-0.234); the Speech, Spatial, and Qualities of Hearing Scale total score improved by 2.58 (95% CI, 2.18-2.99); and a novel Device Use Questionnaire reported 94% of participants were satisfied with overall hearing in the everyday listening condition. Conclusions and Relevance: This subgroup analysis of patients 65 years or older enrolled in a within-subject clinical trial of cochlear implantation demonstrated clinically meaningful audiometric and QoL benefit with an acceptable risk profile. These findings suggest that cochlear implantation in older adults may facilitate the concept of healthy aging. Trial Registration: ClinicalTrials.gov Identifier: NCT03007472.

Assessment of Speech Understanding After Cochlear Implantation in Adult Hearing Aid Users: A Nonrandomized Controlled Trial.

Importance: Cochlear implants were approved for use in adults in the 1980s, but use remains low owing to a lack of awareness regarding cochlear implantation candidacy criteria and expected outcomes. There have been limited, small series examining the safety and effectiveness of cochlear implantation in adult hearing aid (HA) users with and without mild cognitive impairment (MCI). Objective: To investigate the safety and effectiveness of a single-ear cochlear implant in a group of optimized adult HA users with and without MCI across a variety of domains. Design, Setting, and Participants: In this nonrandomized controlled trial, a multicenter, prospective, repeated-measures investigation was conducted at 13 US institutions. The setting was academic and community-based cochlear implant programs. Eligible participants were 100 adults (aged >18 years) with postlinguistic onset of bilateral moderate sloping to profound or worse sensorineural hearing loss (≤20 years' duration). Fluent English speakers underwent an optimized bilateral HA trial for at least 30 days. Individuals with aided Consonant-Vowel Nucleus-Consonant (CNC) word score in quiet of 40% or less correct in the ear to be implanted and 50% or less correct in the contralateral ear were offered cochlear implants. The first participant was enrolled on February 20, 2017, and the last participant was enrolled on May 3, 2018. The final follow-up was on December 21, 2018. Interventions: Participants received the same cochlear implant system and contralateral HA. Main Outcomes and Measures: The primary outcome measure was speech understanding in quiet (CNC word score) using both the cochlear implant and opposite ear HA. Secondary outcome measures included the following: adverse events; speech understanding in noise (AzBio signal-to-noise ratio of +10 db [+10 SNR]) Health Utilities Index Mark 3 (HUI3); Speech, Spatial, and Qualities of Hearing Questionnaire 49 (SSQ49); and Montreal Cognitive Assessment (MoCA). Results: The median age at cochlear implantation of the 96 patients included in the trial was 71 years (range, 23-91 years), and 62 patients (65%) were male. Three serious adverse events requiring revision surgery occurred, and all resolved without sequelae. By 6 months after activation, the absolute marginal mean change in CNC word score and AzBio +10 SNR was 40.5% (95% CI, 35.9%-45.0%) and 24.1% (95% CI, 18.9%-29.4%), respectively. Ninety-one percent (87 of 96) of participants had a clinically important improvement (>15%) in the CNC word score in the implant ear. Mild cognitive impairment (MoCA total score ≤25) was observed in 48 of 81 study participants (59%) at baseline. Speech perception marginal mean improvements were similar between individuals with and without baseline MCI, with values of 40.9% (95% CI, 35.2%-46.6%) and 39.6% (95% CI, 31.8%-47.4%), respectively, for CNC word score and 27.5% (95% CI, 21.0%-33.9%) and 17.8% (95% CI, 9.0%-26.6%), respectively, for AzBio +10 SNR. Statistically significant and clinically important improvements in the HUI3 and SSQ49 were evident at 6 months. Conclusions and Relevance: The findings of this nonrandomized controlled trial seem to indicate that cochlear implants are safe and effective in restoring speech understanding in both quiet and noise and improve quality of life in individuals with and without MCI. Trial Registration: ClinicalTrials.gov Identifier: NCT03007472.

Effects of Electrode Location on Estimates of Neural Health in Humans with Cochlear Implants.

There are a number of psychophysical and electrophysiological measures that are correlated with SGN density in animal models, and these same measures can be performed in humans with cochlear implants (CIs). Thus, these measures are potentially applicable in humans for estimating the condition of the neural population (so called "neural health" or "cochlear health") at individual sites along the electrode array and possibly adjusting the stimulation strategy in the CI sound processor accordingly. Some measures used to estimate neural health in animals have included the electrically evoked compound potential (ECAP), psychophysical detection thresholds, and multipulse integration (MPI). With regard to ECAP measures, it has been shown that the change in the ECAP response as a function of increasing the stimulus interphase gap ("IPG Effect") also reflects neural density in implanted animals. These animal studies have typically been conducted using preparations in which the electrode was in a fixed position with respect to the neural population, whereas in human cochlear implant users, the position of individual electrodes varies widely within an electrode array and also across subjects. The current study evaluated the effects of electrode location in the implanted cochlea (specifically medial-lateral location) on various electrophysiological and psychophysical measures in eleven human subjects. The results demonstrated that some measures of interest, specifically ECAP thresholds, psychophysical detection thresholds, and ECAP amplitude-growth function (AGF) linear slope, were significantly related to the distances between the electrode and mid-modiolar axis (MMA). These same measures were less strongly related or not significantly related to the electrode to medial wall (MW) distance. In contrast, neither the IPG Effect for the ECAP AGF slope or threshold, nor the MPI slopes were significantly related to MMA or MW distance from the electrodes. These results suggest that "within-channel" estimates of neural health such as the IPG Effect and MPI slope might be more suitable for estimating nerve condition in humans for clinical application since they appear to be relatively independent of electrode position.

Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey.

BACKGROUND: Single-sided deafness (SSD) describes the presence of a unilateral severe to profound sensorineural hearing loss. SSD disrupts spatial hearing and understanding speech in background noise. It has functional, psychological and social consequences. Potential options for rehabilitation include hearing aids and auditory implants. Benefits and harms of these interventions are documented inconsistently in the literature, using a variety of outcomes ranging from tests of speech perception to quality of life questionnaires. It is therefore difficult to compare interventions when rehabilitating SSD. The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study is an international initiative that aims to develop a minimum set of core outcomes for use in future trials of SSD interventions. METHODS/DESIGN: The CROSSSD study adopts an international two-round online modified Delphi survey followed by a stakeholder consensus meeting to identify a patient-centred core outcome domain set for SSD based on what is considered critical and important for assessing whether an intervention for SSD has worked. DISCUSSION: The resulting core outcome domain set will act as a minimum standard for reporting in future clinical trials and could have further applications in guiding the use of outcome measures in clinical practice. Standardisation will facilitate comparison of research findings.

Correction to: Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study: protocol for an international consensus on outcome measures for single sided deafness interventions using a modified Delphi survey.

Following the publication of our article [1], the authors have notified us of a typo in the third bullet point of the Consensus Criteria section.

Effects of Early Acoustic Hearing on Speech Perception and Language for Pediatric Cochlear Implant Recipients.

Purpose The overall goal of the current study was to identify an optimal level and duration of acoustic experience that facilitates language development for pediatric cochlear implant (CI) recipients-specifically, to determine whether there is an optimal duration of hearing aid (HA) use and unaided threshold levels that should be considered before proceeding to bilateral CIs. Method A total of 117 pediatric CI recipients (ages 5-9 years) were given speech perception and standardized tests of receptive vocabulary and language. The speech perception battery included tests of segmental perception (e.g., word recognition in quiet and noise, and vowels and consonants in quiet) and of suprasegmental perception (e.g., talker and stress discrimination, and emotion identification). Hierarchical regression analyses were used to determine the effects of speech perception on language scores, and the effects of residual hearing level (unaided pure-tone average [PTA]) and duration of HA use on speech perception. Results A continuum of residual hearing levels and the length of HA use were represented by calculating the unaided PTA of the ear with the longest duration of HA use for each child. All children wore 2 devices: Some wore bimodal devices, while others received their 2nd CI either simultaneously or sequentially, representing a wide range of HA use (0.03-9.05 years). Regression analyses indicate that suprasegmental perception contributes unique variance to receptive language scores and that both segmental and suprasegmental skills each contribute independently to receptive vocabulary scores. Also, analyses revealed an optimal duration of HA use for each of 3 ranges of hearing loss severity (with mean PTAs of 73, 92, and 111 dB HL) that maximizes suprasegmental perception. Conclusions For children with the most profound losses, early bilateral CIs provide the greatest opportunity for developing good spoken language skills. For those with moderate-to-severe losses, however, a prescribed period of bimodal use may be more advantageous for developing good spoken language skills.

Front- and rear-facing horizontal sound localization results in adults with unilateral hearing loss and normal hearing.

Binaural hearing allows listeners to take advantage of auditory cues that are necessary for sound localization. Patients with asymmetric or unilateral hearing loss receive degraded or absent binaural cues and often demonstrate decreased sound localization in the horizontal plane. Given the importance of sound localization for everyday function, there is a need for clinically feasible methods to evaluate localization, particularly as validation of intervention for patients with unilateral hearing loss. The present study compared sound localization results obtained for front-facing and rear-facing soundfield systems and for a rear-facing head related transfer function (HRTF) system in two hearing groups, listeners with normal hearing and those with unilateral hearing loss. Results between the three systems were highly correlated and repeatable. Neither age nor a pure-tone average of 0.5, 1, 2 and 4 kHz correlated with localization performance among normal hearing participants. Among the UHL group, age and onset of severe to profound hearing loss were positively correlated with localization results; length of deafness was negatively correlated. Behavioral chance performance was established for localization with rear-facing HRTF and rear-facing soundfield test systems; group mean results for unilateral hearing loss participants were significantly better than chance. Continued work is needed in developing clinically feasible evaluation methods for patients with asymmetric or unilateral hearing loss, particularly as the effects of treatment options are assessed.

Evaluation of a New Algorithm to Optimize Audibility in Cochlear Implant Recipients.

OBJECTIVES: A positive relation between audibility and speech understanding has been established for cochlear implant (CI) recipients. Sound field thresholds of 20 dB HL across the frequency range provide CI users the opportunity to understand soft and very soft speech. However, programming the sound processor to attain good audibility can be time-consuming and difficult for some patients. To address these issues, Advanced Bionics (AB) developed the SoftVoice algorithm designed to remove system noise and thereby improve audibility of soft speech. The present study aimed to evaluate the efficacy of SoftVoice in optimizing AB CI recipients' soft-speech perception. DESIGN: Two studies were conducted. Study 1 had two phases, 1A and 1B. Sixteen adult, AB CI recipients participated in Study 1A. Acute testing was performed in the unilateral CI condition using a Harmony processor programmed with participants' everyday-use program (Everyday) and that same program but with SoftVoice implemented. Speech recognition measures were administered at several presentation levels in quiet (35 to 60 dB SPL) and in noise (60 dB SPL). In Study 1B, 10 of the participants compared Everyday and SoftVoice at home to obtain feedback regarding the use of SoftVoice in various environments. During Study 2, soft-speech perception was acutely measured with Everyday and SoftVoice for 10 participants using the Naida CI Q70 processor. Results with the Harmony (Study 1A) and Naida processors were compared. Additionally, Study 2 evaluated programming options for setting electrode threshold levels (T-levels or Ts) to improve the usability of SoftVoice in daily life. RESULTS: Study 1A showed significantly higher scores with SoftVoice than Everyday at soft presentation levels (35, 40, 45, and 50 dB SPL) and no significant differences between programs at a conversational level (60 dB SPL) in quiet or in noise. After take-home experience with SoftVoice and Everyday (Study 1B), 5 of 10 participants reported preferring SoftVoice over Everyday; however, 6 reported bothersome environmental sound when listening with SoftVoice at home. Results of Study 2 indicated similar soft-speech perception between Harmony and Naida processors. Additionally, implementing SoftVoice with Ts at the manufacturer's default setting of 10% of Ms reduced reports of bothersome environmental sound during take-home experience; however, soft-speech perception was best with SoftVoice when Ts were behaviorally set above 10% of Ms. CONCLUSIONS: Results indicate that SoftVoice may be a potential tool for optimizing AB users' audibility and, in turn, soft-speech perception. To achieve optimal performance at soft levels and comfortable use in daily environments, setting Ts must be considered with SoftVoice. Future research should examine program parameters that may benefit soft-speech perception when used in combination with SoftVoice (e.g., increased input dynamic range).

Results in Adult Cochlear Implant Recipients With Varied Asymmetric Hearing: A Prospective Longitudinal Study of Speech Recognition, Localization, and Participant Report.

OBJECTIVES: Asymmetric hearing with severe to profound hearing loss (SPHL) in one ear and better hearing in the other requires increased listening effort and is detrimental for understanding speech in noise and sound localization. Although a cochlear implant (CI) is the only treatment that can restore hearing to an ear with SPHL, current candidacy criteria often disallows this option for patients with asymmetric hearing. The present study aimed to evaluate longitudinal performance outcomes in a relatively large group of adults with asymmetric hearing who received a CI in the poor ear. DESIGN: Forty-seven adults with postlingual hearing loss participated. Test materials included objective and subjective measures meant to elucidate communication challenges encountered by those with asymmetric hearing. Test intervals included preimplant and 6 and 12 months postimplant. Preimplant testing was completed in participants' everyday listening condition: bilateral hearing aids (HAs) n = 9, better ear HA n = 29, and no HA n = 9; postimplant, each ear was tested separately and in the bimodal condition. RESULTS: Group mean longitudinal results in the bimodal condition postimplant compared with the preimplant everyday listening condition indicated significantly improved sentence scores at soft levels and in noise, improved localization, and higher ratings of communication function by 6 months postimplant. Group mean, 6-month postimplant results were significantly better in the bimodal condition compared with either ear alone. Audibility and speech recognition for the poor ear alone improved significantly with a CI compared with preimplant. Most participants had clinically meaningful benefit on most measures. Contributory factors reported for traditional CI candidates also impacted results for this population. In general, older participants had poorer bimodal speech recognition in noise and localization abilities than younger participants. Participants with early SPHL onset had better bimodal localization than those with later SPHL onset, and participants with longer SPHL duration had poorer CI alone speech understanding in noise but not in quiet. Better ear pure-tone average (PTA) correlated with all speech recognition measures in the bimodal condition. To understand the impact of better ear hearing on bimodal performance, participants were grouped by better ear PTA: group 1 PTA ≤40 dB HL (n = 19), group 2 PTA = 41 to 55 dB HL (n = 14), and group 3 PTA = 56 to 70 dB HL (n = 14). All groups showed bimodal benefit on speech recognition measures in quiet and in noise; however, only group 3 obtained benefit when noise was toward the CI ear. All groups showed improved localization and ratings of perceived communication. CONCLUSIONS: Receiving a CI for the poor ear was an effective treatment for this population. Improved audibility and speech recognition were evident by 6 months postimplant. Improvements in sound localization and self-reports of communication benefit were significant and not related to better ear hearing. Participants with more hearing in the better ear (group 1) showed less bimodal benefit but greater bimodal performance for speech recognition than groups 2 and 3. Test batteries for this population should include quality of life measures, sound localization, and adaptive speech recognition measures with spatially separated noise to capture the hearing loss deficits and treatment benefits reported by this patient population.

Unilateral Hearing Loss: Understanding Speech Recognition and Localization Variability-Implications for Cochlear Implant Candidacy.

OBJECTIVES: At a minimum, unilateral hearing loss (UHL) impairs sound localization ability and understanding speech in noisy environments, particularly if the loss is severe to profound. Accompanying the numerous negative consequences of UHL is considerable unexplained individual variability in the magnitude of its effects. Identification of covariables that affect outcome and contribute to variability in UHLs could augment counseling, treatment options, and rehabilitation. Cochlear implantation as a treatment for UHL is on the rise yet little is known about factors that could impact performance or whether there is a group at risk for poor cochlear implant outcomes when hearing is near-normal in one ear. The overall goal of our research is to investigate the range and source of variability in speech recognition in noise and localization among individuals with severe to profound UHL and thereby help determine factors relevant to decisions regarding cochlear implantation in this population. DESIGN: The present study evaluated adults with severe to profound UHL and adults with bilateral normal hearing. Measures included adaptive sentence understanding in diffuse restaurant noise, localization, roving-source speech recognition (words from 1 of 15 speakers in a 140° arc), and an adaptive speech-reception threshold psychoacoustic task with varied noise types and noise-source locations. There were three age-sex-matched groups: UHL (severe to profound hearing loss in one ear and normal hearing in the contralateral ear), normal hearing listening bilaterally, and normal hearing listening unilaterally. RESULTS: Although the normal-hearing-bilateral group scored significantly better and had less performance variability than UHLs on all measures, some UHL participants scored within the range of the normal-hearing-bilateral group on all measures. The normal-hearing participants listening unilaterally had better monosyllabic word understanding than UHLs for words presented on the blocked/deaf side but not the open/hearing side. In contrast, UHLs localized better than the normal-hearing unilateral listeners for stimuli on the open/hearing side but not the blocked/deaf side. This suggests that UHLs had learned strategies for improved localization on the side of the intact ear. The UHL and unilateral normal-hearing participant groups were not significantly different for speech in noise measures. UHL participants with childhood rather than recent hearing loss onset localized significantly better; however, these two groups did not differ for speech recognition in noise. Age at onset in UHL adults appears to affect localization ability differently than understanding speech in noise. Hearing thresholds were significantly correlated with speech recognition for UHL participants but not the other two groups. CONCLUSIONS: Auditory abilities of UHLs varied widely and could be explained only in part by hearing threshold levels. Age at onset and length of hearing loss influenced performance on some, but not all measures. Results support the need for a revised and diverse set of clinical measures, including sound localization, understanding speech in varied environments, and careful consideration of functional abilities as individuals with severe to profound UHL are being considered potential cochlear implant candidates.

A Longitudinal Study in Children With Sequential Bilateral Cochlear Implants: Time Course for the Second Implanted Ear and Bilateral Performance.

Purpose: Whether, and if so when, a second-ear cochlear implant should be provided to older, unilaterally implanted children is an ongoing clinical question. This study evaluated rate of speech recognition progress for the second implanted ear and with bilateral cochlear implants in older sequentially implanted children and evaluated localization abilities. Method: A prospective longitudinal study included 24 bilaterally implanted children (mean ear surgeries at 5.11 and 14.25 years). Test intervals were every 3-6 months through 24 months postbilateral. Test conditions were each ear and bilaterally for speech recognition and localization. Results: Overall, the rate of progress for the second implanted ear was gradual. Improvements in quiet continued through the second year of bilateral use. Improvements in noise were more modest and leveled off during the second year. On all measures, results from the second ear were poorer than the first. Bilateral scores were better than either ear alone for all measures except sentences in quiet and localization. Conclusions: Older sequentially implanted children with several years between surgeries may obtain speech understanding in the second implanted ear; however, performance may be limited and rate of progress gradual. Continued contralateral ear hearing aid use and reduced time between surgeries may enhance outcomes.