The effect of the CONSORT statement on the amount of "unclear" Risk of Bias reporting in Cochrane Systematic Reviews.

BACKGROUND: The Consolidated Standards of Reporting Trials (CONSORT) statement aims to improve clarity and consistency of transparency of reporting in Randomized Controlled Trials (RCTs). The Cochrane Risk of Bias (RoB) tool for RCTs helps authors to judge the RoB. as ''low", "high" or "unclear". OBJECTIVE: In this study we aimed to assess whether the implementation and updates of the CONSORT statement influenced the trend of "unclear" RoB scores of RCTs included in Cochrane systematic reviews. METHODS: All Cochrane reviews published in December to October 2016 were retrieved. The publication year of RCTS included in the reviews were sorted into time frames (≤1995, 1996-2000, 2001-2009 and ≥2010) based on the release- and updates of the CONSORT statement (1996, 2001 and 2010). The association between "unclear" RoB versus "low or high" RoB and the year of publication in different time frames were calculated using a binary logistic regression. RESULTS: Data was extracted from 64 Cochrane reviews, with 989 RCTS (6471 items). The logistic regression showed that the odds of RCTs published ≥2010, compared to ≤1995 were more likely not to report an "unclear" RoB for the total data (Odds Ratio (OR) 0.69 (95% Confidence interval: 0.59-0.80)), random sequence generation (OR 0.32 (0.22-0.47), allocation concealment (0.64 (0.43-0.95)) and incomplete outcome data (OR 0.60 (0.39-0.91)). CONCLUSION: A slight decrease of "unclear" RoB reporting over time was found. To improve quality of reporting authors are encouraged to adhere to reporting guidelines.

Publications on Clinical Research in Otolaryngology-A Systematic Analysis of Leading Journals in 2010.

Background: We wanted to asses and characterize the volume of Otolaryngology publications on clinical research, published in major journals. Methods and Material: To assess volume and study type of clinical research in Otolaryngology we performed a literature search in high impact factor journals. We included 10 high impact factor Otolaryngology journals and 20 high impact factor medical journals outside this field (2011). We extracted original publications and systematic reviews from 2010. Publications were classified according to their research question, that is therapy, diagnosis, prognosis or etiology. Results: From Otolaryngology journals (impact factor 1.8 to 2.8) we identified 694 (46%) publications on original observations and 27 (2%) systematic reviews. From selected medical journals (impact factor 6.0 to 101.8) 122 (2%) publications related to Otolaryngology, 102 (83%) were on original observations and 2 (0.04%) systematic reviews. The most common category was therapy (40%). Conclusion: Half of publications in Otolaryngology concerns clinical research, which is higher than other specialties. In medical journals outside the field of Otolaryngology, a small proportion (2%) of publications is related to Otolaryngology. Striking is that systematic reviews, which are considered high level evidence, make up for only 2% of publications. We must ensure an increase of clinical research for optimizing medical practice.

No Difference in Behavioral and Self-Reported Outcomes for Simultaneous and Sequential Bilateral Cochlear Implantation: Evidence From a Multicenter Randomized Controlled Trial.

Objective: The primary aim of this study was to longitudinally compare the behavioral and self-reported outcomes of simultaneous bilateral cochlear implantation (simBiCI) and sequential BiCI (seqBiCI) in adults with severe-to-profound postlingual sensorineural hearing loss. Design: This study is a multicenter randomized controlled trial with a 4-year follow-up period after the first moment of implantation. Participants were allocated by randomization to receive bilateral cochlear implants (CIs) either, simultaneously (simBiCI group) or sequentially with an inter-implant interval of 2 years (UCI/seqBiCI group). All sequential patients where encouraged to use their hearing aid on the non-implanted ear over of the first 2 years. Patients were followed-up on an annual basis. The primary outcome was speech perception in noise coming from a source directly in front of the patient. Other behavioral outcome measures were speech intelligibility-in-noise from spatially separated sources, localization and speech perception in quiet. Self-reported outcome measures encompassed questionnaires on quality of life, quality of hearing and tinnitus. All outcome measures were analyzed longitudinally using a linear or logistic regression analysis with an autoregressive residual covariance matrix (generalized estimating equations type). Results: Nineteen participants were randomly allocated to the simBiCI group and 19 participants to the UCI/seqBiCI group. Three participants in the UCI/seqBiCI group did not proceed with their second implantation and were therefore unavailable for follow-up. Both study groups performed equally well on speech perception in noise from a source directly in front of the patient longitudinally. During all 4 years of follow-up the UCI/seqBiCI group performed significantly worse compared to the simBiCI group on spatial speech perception in noise in the best performance situation (8.70 dB [3.96 - 13.44], p < 0.001) and localization abilities (largest difference 60 degrees configuration: -44.45% [-52.15 - -36.74], p < 0.0001). Furthermore, during all years of follow-up, the UCI/seqBiCI group performed significantly worse on quality of hearing and quality of life questionnaires. The years of unilateral CI use were the reason for the inferior results in the UCI/SeqBiCI group. One year after receiving CI2, the UCI/seqBiCI group performance did not statistically differ from the performance of the simBiCI group on all these outcomes. Furthermore, no longitudinal differences were seen in tinnitus burden prevalence between groups. Finally, the complications that occurred during this trial were infection, dysfunction of CI, facial nerve palsy, tinnitus and vertigo. Conclusion: This randomized controlled trial on bilaterally severely hearing impaired participants found a significantly worse longitudinal performance of UCI/seqBiCI compared to simBiCI on multiple behavioral and self-reported outcomes regarding speech perception in noise and localization abilities. This difference is associated with the inferior performance of the UCI/seqBiCI participants during the years of unilateral CI use. After receiving the second CI however, the performance of the UCI/seqBiCI group did not significantly differ from the simBiCI group. Trial Registration: Dutch Trial Register NTR1722.

No Squelch Effect After Sequential Bilateral Cochlear Implantation in Postlingually Deafened Adults: Is There a First Ear Advantage?

OBJECTIVES: To investigate whether a squelch effect develops in postlingually deafened adults after sequential bilateral cochlear implantation. STUDY DESIGN: Prospective study as part of a randomized controlled trial on the difference between simultaneous versus sequential bilateral cochlear implantation. SETTING: Tertiary referral center. PARTICIPANTS: Sixteen postlingually deafened adults. INTERVENTION: Sequential bilateral cochlear implantation with a 2-year interimplant interval. MAIN OUTCOME MEASURE: A squelch effect was defined as a better bilateral score than unilateral score on a speech-intelligibility-in-noise test with spatially separated sources. The squelch effect was evaluated for the participants' best performing cochlear implant (CI) ear, the left CI in the condition with speech from -60 degrees azimuth and noise from +60 degrees azimuth (S-60 N+60), the right CI (N-60 S+60), CI1 and CI2. Evaluations took place 1, 2 and median 4 years after sequential implantation. RESULTS: No significant squelch effect was found, except for the right CI (N-60 S+60) after 2 years. No differences in speech perception-in-noise from straight ahead were seen between CI1 and CI2. Comparing performance of participants whose better or worse ear was implanted first did not reveal differences either. For the best performing situation, 7/16, 6/16, and 3/12 participants exhibited a squelch effect after 1, 2, and 4 years of follow-up. CONCLUSIONS: Participants who underwent sequential bilateral cochlear implantation with a 2-year interimplant interval did not develop an evident squelch effect on group level after a median follow-up of 4 years. Individual participants were able to make use of the squelch effect. The less evident squelch effect is at odds with our group of simultaneously implanted bilateral cochlear implant users. Neither a difference between CI1 and CI2, nor implanting the better or worse ear first could explain the less evident squelch effect in these patients. TRIAL REGISTRATION: Dutch Trial Register NTR1722.

Development and internal validation of a multivariable prediction model for tinnitus recovery following unilateral cochlear implantation: a cross-sectional retrospective study.

OBJECTIVE: To develop and internally validate a prediction model for tinnitus recovery following unilateral cochlear implantation. DESIGN: A cross-sectional retrospective study. SETTING: A questionnaire concerning tinnitus was sent to patients with bilateral severe to profound hearing loss, who underwent unilateral cochlear implantation at the University Medical Center Utrecht, the Netherlands, between 1 January 2006 and 31 December 2015. PARTICIPANTS: Of 137 included patients, 87 patients experienced tinnitus preoperatively. Data of these 87 patients were used to develop the prediction model. PRIMARY AND SECONDARY OUTCOME MEASURES: The outcome of the prediction model was tinnitus recovery. Investigated predictors were: age, gender, duration of deafness, preoperative hearing performance, tinnitus duration, severity and localisation, follow-up duration, localisation of cochlear implant (CI) compared with tinnitus side, surgical approach, insertion depth of the electrode, CI brand and difference in hearing threshold following cochlear implantation. Multivariable backward logistic regression was performed. Missing data were handled using multiple imputation. The performance of the model was assessed by the calibrative and discriminative ability of the model. The prediction model was internally validated using bootstrapping techniques. RESULTS: The tinnitus recovery rate was 40%. A lower preoperative Consonant-Vowel-Consonant (CVC) score, unilateral localisation of tinnitus and larger deterioration of residual hearing at 250 Hz revealed to be relevant predictors for tinnitus recovery. The area under the receiver operating characteristics curve (AUC) of the initial model was 0.722 (IQR: 0.703-0.729). After internal validation of this prediction model, the AUC decreased to 0.696 (IQR: 0.667-0.700). CONCLUSION AND RELEVANCE: Lower preoperative CVC score, unilateral localisation of tinnitus and larger deterioration of residual hearing at 250 Hz were significant predictors for tinnitus recovery following unilateral cochlear implantation. The performance of the model developed in this retrospective study is promising. However, before clinical use of the model, the conduction of a larger prospective study is recommended.

Correlation between subjective and objective hearing tests after unilateral and bilateral cochlear implantation.

BACKGROUND: There are many methods for assessing hearing performance after cochlear implantation. Standard evaluations often encompass objective hearing tests only, while patients' subjective experiences gain importance in today's healthcare. The aim of the current study was to analyze the correlation between subjective (self-reported questionnaires) and objective (speech perception and localization) hearing test results in adult cochlear implant (CI) users. Secondary, the correlation between subjective and objective hearing tests was compared between bilateral and unilateral CI patients. METHODS: Data for this study were prospectively collected as part of a multicentre randomized controlled trial. Thirty-eight postlingually deafened adult patients were randomly allocated to receive either unilateral (n = 19) or bilateral (n = 19) cochlear implantation. We used data gathered after one year of follow-up. We studied the correlation between objectively measured speech perception and localization skills on the one hand and related domains of the Speech, Spatial and Qualities of Hearing Scale (SSQ) and Nijmegen Cochlear Implant Questionnaire (NCIQ) on the other hand. We also compared these correlations between unilateral and bilateral CI users. RESULTS: We found significant weak to moderate negative correlations between the subjective test results (speech domain of the SSQ and the advanced speech perception domain of the NCIQ) and the related objective speech perception in noise test results (r = -0.33 to -0.48). A significant moderate correlation was found between the subjective test results (spatial domain of the SSQ) and the related objective localization test results (r = 0.59). The correlations in the group of bilateral CI patients (r = -0.28 to -0.54) did not differ significantly from the correlations in the group of unilateral CI patients (r = 0.15 to -0.40). CONCLUSIONS: Current objective tests do not fully reflect subjective everyday listening situations. This study elucidates the importance and necessity of questionnaires in the evaluation of cochlear implantation. Therefore, it is advised to evaluate both objective and subjective tests in CI patients on a regular basis. TRIAL REGISTRATION: This trial was registered on March 11, 2009 in the Dutch Trial Register. Trial registration number: NTR1722.

Tinnitus after Simultaneous and Sequential Bilateral Cochlear Implantation.

IMPORTANCE: There is an ongoing global discussion on whether or not bilateral cochlear implantation should be standard care for bilateral deafness. Contrary to unilateral cochlear implantation, however, little is known about the effect of bilateral cochlear implantation on tinnitus. OBJECTIVE: To investigate tinnitus outcomes 1 year after bilateral cochlear implantation. Secondarily, to compare tinnitus outcomes between simultaneous and sequential bilateral cochlear implantation and to investigate long-term follow-up (3 years). STUDY DESIGN: This study is a secondary analysis as part of a multicenter randomized controlled trial. METHODS: Thirty-eight postlingually deafened adults were included in the original trial, in which the presence of tinnitus was not an inclusion criterion. All participants received cochlear implants (CIs) because of profound hearing loss. Nineteen participants received bilateral CIs simultaneously and 19 participants received bilateral CIs sequentially with an inter-implant interval of 2 years. The prevalence and severity of tinnitus before and after simultaneous and sequential bilateral cochlear implantation were measured preoperatively and each year after implantation with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ). RESULTS: The prevalence of preoperative tinnitus was 42% (16/38). One year after bilateral implantation, there was a median difference of -8 (inter-quartile range (IQR): -28 to 4) in THI score and -9 (IQR: -17 to -9) in TQ score in the participants with preoperative tinnitus. Induction of tinnitus occurred in five participants, all in the simultaneous group, in the year after bilateral implantation. Although the preoperative and also the postoperative median THI and TQ scores were higher in the simultaneous group, the median difference scores were equal in both groups. In the simultaneous group, tinnitus scores fluctuated in the 3 years after implantation. In the sequential group, four patients had an additional benefit of the second CI: a total suppression of tinnitus compared with their unilateral situation. CONCLUSION: While bilateral cochlear implantation can have a positive effect on preoperative tinnitus complaints, the induction of (temporary or permanent) tinnitus was also reported. CLINICAL TRIAL REGISTRATION: Dutch Trial Register NTR1722.

Objective and Subjective Measures of Simultaneous vs Sequential Bilateral Cochlear Implants in Adults: A Randomized Clinical Trial.

Importance: To date, no randomized clinical trial on the comparison between simultaneous and sequential bilateral cochlear implants (BiCIs) has been performed. Objective: To investigate the hearing capabilities and the self-reported benefits of simultaneous BiCIs compared with those of sequential BiCIs. Design, Setting, and Participants: A multicenter randomized clinical trial was conducted between January 12, 2010, and September 2, 2012, at 5 tertiary referral centers among 40 participants eligible for BiCIs. Main inclusion criteria were postlingual severe to profound hearing loss, age 18 to 70 years, and a maximum duration of 10 years without hearing aid use in both ears. Data analysis was conducted from May 24 to June 12, 2016. Interventions: The simultaneous BiCI group received 2 cochlear implants during 1 surgical procedure. The sequential BiCI group received 2 cochlear implants with an interval of 2 years between implants. Main Outcomes and Measures: First, the results 1 year after receiving simultaneous BiCIs were compared with the results 1 year after receiving sequential BiCIs. Second, the results of 3 years of follow-up for both groups were compared separately. The primary outcome measure was speech intelligibility in noise from straight ahead. Secondary outcome measures were speech intelligibility in noise from spatially separated sources, speech intelligibility in silence, localization capabilities, and self-reported benefits assessed with various hearing and quality of life questionnaires. Results: Nineteen participants were randomized to receive simultaneous BiCIs (11 women and 8 men; median age, 52 years [interquartile range, 36-63 years]), and another 19 participants were randomized to undergo sequential BiCIs (8 women and 11 men; median age, 54 years [interquartile range, 43-64 years]). Three patients did not receive a second cochlear implant and were unavailable for follow-up. Comparable results were found 1 year after simultaneous or sequential BiCIs for speech intelligibility in noise from straight ahead (difference, 0.9 dB [95% CI, -3.1 to 4.4 dB]) and all secondary outcome measures except for localization with a 30° angle between loudspeakers (difference, -10% [95% CI, -20.1% to 0.0%]). In the sequential BiCI group, all participants performed significantly better after the BiCIs on speech intelligibility in noise from spatially separated sources and on all localization tests, which was consistent with most of the participants' self-reported hearing capabilities. Speech intelligibility-in-noise results improved in the simultaneous BiCI group up to 3 years following the BiCIs. Conclusions and Relevance: This study shows comparable objective and subjective hearing results 1 year after receiving simultaneous BiCIs and sequential BiCIs with an interval of 2 years between implants. It also shows a significant benefit of sequential BiCIs over a unilateral cochlear implant. Until 3 years after receiving simultaneous BiCIs, speech intelligibility in noise significantly improved compared with previous years. Trial Registration: trialregister.nl Identifier: NTR1722.

Stable benefits of bilateral over unilateral cochlear implantation after two years: A randomized controlled trial.

OBJECTIVES/HYPOTHESIS: To investigate hearing capabilities and self-reported benefits of simultaneous bilateral cochlear implantation (BiCI) compared with unilateral cochlear implantation (UCI) after a 2-year follow-up and to evaluate the learning effect of cochlear implantees over time. STUDY DESIGN: Multicenter randomized controlled trial. METHODS: Thirty-eight postlingually deafened adults were included in this study and randomly allocated to either UCI or simultaneous BiCI. Our primary outcome was speech intelligibility in noise, with speech and noise coming from straight ahead (Utrecht-Sentence Test with Adaptive Randomized Roving levels). Secondary outcomes were speech intelligibility in noise with spatially separated sources, speech intelligibility in silence (Dutch phoneme test), localization capabilities and self-reported benefits assessed with different quality of hearing and quality of life (QoL) questionnaires. This article describes the results after 2 years of follow-up. RESULTS: We found comparable results for the UCI and simultaneous BiCI group, when speech and noise were both presented from straight ahead. Patients in the BiCI group performed significantly better than patients in the UCI group, when speech and noise came from different directions (P = .01). Furthermore, their localization capabilities were significantly better. These results were consistent with patients' self-reported hearing capabilities, but not with the questionnaires regarding QoL. We found no significant differences on any of the subjective and objective reported outcomes between the 1-year and 2-year follow-up. CONCLUSIONS: This study demonstrates important benefits of simultaneous BiCI compared with UCI that remain stable over time. Bilaterally implanted patients benefit significantly in difficult everyday listening situations such as when speech and noise come from different directions. Furthermore, bilaterally implanted patients are able to localize sounds, which is impossible for unilaterally implanted patients. LEVEL OF EVIDENCE: 1b Laryngoscope, 127:1161-1168, 2017.

Development of a Squelch Effect in Adult Patients After Simultaneous Bilateral Cochlear Implantation.

OBJECTIVES: To investigate whether a squelch effect occurs in the first 3 years after simultaneous bilateral cochlear implantation and to investigate whether this effect increases during follow-up. STUDY DESIGN: Prospective study as part of a multicenter randomized controlled trial that compares simultaneous bilateral cochlear implantation to sequential and unilateral cochlear implantation. SETTING: Tertiary referral center. PATIENTS: Nineteen postlingually deafened adults. INTERVENTION: Simultaneous bilateral cochlear implantation. MAIN OUTCOME MEASURE: The squelch effect, measured yearly with a speech-intelligibility-in-noise test with spatially separated sources. Bilateral results were compared to unilateral results in which the cochlear implant at the noise side was turned off. The squelch effect was investigated for the patients' best performing ear and for the left and right ears separately. RESULTS: In 13 individual patients, a squelch effect was present after 1 year. This number increased during follow-up years. On group level, a squelch effect was present in patients' best performing ear after 2 and 3 years (1.9 dB). A squelch effect was present in both ears after 3 years (AS: 1.7 dB, AD: 1.3 dB). CONCLUSION: Patients who underwent simultaneous bilateral cochlear implantation developed a measurable benefit from the squelch effect after 2 years in their best performing ear and after 3 years in both ears. These observations suggest that the brain learns to use interaural differences to segregate sound from noise after simultaneous bilateral cochlear implantation. The squelch effect increased over time which suggests a growth in cortical integration and differentiation of inputs from bilateral CIs due to brain plasticity. TRIAL REGISTRATION: Dutch Trial Register NTR1722. LEVEL OF EVIDENCE: 1b.

Effectiveness of Earplugs in Preventing Recreational Noise-Induced Hearing Loss: A Randomized Clinical Trial.

IMPORTANCE: The incidence of hearing loss has risen in past years. Attendance at music festivals and concerts may contribute to this increasing problem. OBJECTIVE: To assess the effectiveness of earplugs in preventing temporary hearing loss immediately following music exposure. DESIGN, SETTING, AND PARTICIPANTS: A randomized, single-blind clinical trial was conducted on September 5, 2015, at an outdoor music festival in Amsterdam, the Netherlands. Normal-hearing adult volunteers were recruited via social media. An exclusion criterion was the participants' intention to wear earplugs. Of the 86 volunteers assessed, 51 were included in the study. All analyses were performed on an intention-to-treat basis. INTERVENTIONS: Participants were randomly assigned to a group using earplugs or an unprotected group during a 4½-hour festival visit. MAIN OUTCOMES AND MEASURES: The primary study outcome was a temporary threshold shift (TTS) on the audiogram, primarily for frequencies at 3 and 4 kHz. Secondary study outcomes included distortion product otoacoustic emission (DPOAE) measurements and claims of tinnitus using a questionnaire and tinnitus matching experiments. RESULTS: Of 51 participants included, 25 were randomized to the earplug group and 26 to the unprotected group. Nine in each group (36% and 35%, respectively) were men, and the mean (SD) ages were 27.3 (5.6) years in the earplug group and 27.0 (6.2) years in the unprotected group. Baseline demographics were similar in both groups. The time-averaged, equivalent A-weighted sound pressure level experienced was 100 dBA during the festival. A TTS over frequencies at 3 and 4 kHz after exposure was seen in 4 of 50 ears (8%) in the earplug group compared with 22 of 52 ears (42%) in the unprotected group (P < .001). The relative risk for a TTS after exposure was 5.3 (95% CI, 2.0-14.3) for the unprotected group vs the earplug group. The number needed to treat with earplugs for preventing 1 TTS was 2.9. The DPOAE amplitudes decreased significantly more over the frequencies 2 to 8 kHz in the unprotected group: the mean (SD) decrease in magnitude was 0.6 (2.8) dB in the earplug group vs 2.2 (1.9) dB in the unprotected group (P = .04). Newly induced tinnitus following sound exposure occurred in 3 of the 25 participants (12%) in the earplug group vs 10 of 25 (40%) in the unprotected group (difference, 28%; 95% CI, 3.6%-49.0%; P = .02). CONCLUSIONS AND RELEVANCE: Earplug use is effective in preventing temporary hearing loss after loud music exposure. The present randomized clinical trial adds proof to the scarce evidence and knowledge on this topic, which is a growing global problem. TRIAL REGISTRATION: trialregister.nl Identifier: NTR5401.

The Effect of Earplugs in Preventing Hearing Loss From Recreational Noise Exposure: A Systematic Review.

IMPORTANCE: The prevalence of hearing loss among children and adolescents is rising dramatically, caused mainly by increased exposure to recreational noise. OBJECTIVE: To present a systematic overview of the effectiveness of wearing earplugs to music venues, such as nightclubs and concert halls, to prevent hearing loss and tinnitus directly after exposure. EVIDENCE ACQUISITION: PubMed, EMBASE, and the Cochrane Library databases were searched for articles from database inception to June 22, 2015, using the keywords music and earplugs and all synonyms. Titles, abstracts, and full text of retrieved articles were screened for eligible articles. The directness of evidence (relevance of the assessed articles) and risk of bias of eligible articles were assessed. For the included articles, the study characteristics and data on our outcomes of interest (hearing loss and tinnitus) were extracted. Data analysis occurred from June 22 to July 3, 2015. FINDINGS: Of 228 articles screened, 4 were eligible for critical appraisal. After critical appraisal, 2 studies with a high directness of evidence and low or moderate risk of bias remained for data extraction. Only 1 of these articles was a randomized clinical trial, which found significantly lower postconcert differences in thresholds and a lower proportion of threshold shifts in the group using earplugs compared with the unprotected group. In the other study, only 3 individuals wore earplugs, and no significant differences were found between the 2 groups. CONCLUSIONS AND RELEVANCE: The available evidence on the effectiveness of earplugs in preventing hearing damage directly after recreational music exposure is scarce. Only 1 well-conducted randomized clinical trial was found, which showed that wearing earplugs to concerts is effective in reducing postconcert threshold shifts. There is a need for further research on this topic to strengthen the level of evidence. Physicians should promote awareness on the risks of recreational noise and recommend the use of earplugs among their patients who visit music venues.

Effect of unilateral and simultaneous bilateral cochlear implantation on tinnitus: A Prospective Study.

OBJECTIVES/HYPOTHESIS: To determine the effect of cochlear implantation on tinnitus perception in patients with severe bilateral postlingual sensorineural hearing loss and to demonstrate possible differences between unilateral and bilateral cochlear implantation. STUDY DESIGN: Prospective study. METHODS: Thirty-eight adult patients were included in this prospective study, as part of a multicenter randomized controlled trial investigating the benefits of bilateral cochlear implantation versus unilateral cochlear implantation. Pre- and postoperative tinnitus perception scores were evaluated, before and 1 year after implantation on three tinnitus questionnaires; the Tinnitus Handicap Inventory (THI), the Tinnitus Questionnaire (TQ), and a visual analogue scale for tinnitus burden. RESULTS: Before implantation, the tinnitus prevalence was 42.1% (16 of 38) in the whole study group. One year after implantation, the tinnitus questionnaire scores had decreased in 71.4% according to the TQ and 80.0% according to the THI. Tinnitus was induced after cochlear implantation in six patients, five in the bilateral and one in the unilateral group. CONCLUSIONS: Our study shows that cochlear implantation is effective in the reduction of tinnitus in patients with bilateral sensorineural hearing loss who suffered from preoperative tinnitus. Conversely, tinnitus may also increase or even be induced by the cochlear implantation itself. Cochlear implant candidates should be well informed about these possible consequences before undergoing surgery. LEVEL OF EVIDENCE: 2b.

Cochlear implantation in children with unilateral hearing loss: A systematic review.

OBJECTIVES: To systematically review the literature on cochlear implantation (CI) for children with unilateral hearing loss (UHL). DATA SOURCES: PubMed, Cochrane, CINAHL, and Embase databases were searched for articles up to June 29, 2015 for UHL, children and CI, and all of their synonyms. METHODS: After screening of titles, abstracts, and full texts for eligible articles, directness of evidence (DoE) and risk of bias (RoB) were assessed for the included articles. Study characteristics and data on our outcomes of interest (speech perception in noise, sound localization, quality of life, and speech and language development) were extracted. RESULTS: In total, 296 unique articles were retrieved, of which five articles satisfied the eligibility criteria. All of these articles were case series or case reports and had a low to moderate DoE and a high RoB. In these studies, heterogeneous findings were reported in small patient samples. Speech perception in noise and localization ability improved in most patients. Although only measured in one study each, quality of life and speech and language development improved. Most of these results were not statistically significant. CONCLUSIONS: No firm conclusions can be drawn on the effectiveness of CI in children with UHL, due to heterogeneous findings, small sample sizes, and the lack of high Level of Evidence studies. Based on the findings of this systematic review, cochlear implantation may be an effective treatment option in children with UHL. Laryngoscope, 126:713-721, 2016.

The effect of cochlear implantation on tinnitus in patients with bilateral hearing loss: A systematic review.

OBJECTIVES: To present an overview of the effect of cochlear implantation on tinnitus in adults with bilateral sensorineural hearing loss. DATA SOURCES: PubMed, Cochrane Library, CINAHL, and Embase databases were searched for articles from database inception up to January 13, 2015. METHODS: A systematic search was conducted. Original studies reporting on cochlear implantation and the effect on tinnitus, measured with a tinnitus questionnaire, were included. The directness of evidence and risk of bias were assessed. Studies with a moderate or high directness of evidence and a low or moderate risk of bias were included for analysis. The pre- and postimplantation tinnitus scores were extracted. RESULTS: In total, 786 unique articles were retrieved. Although there was lack of high level of evidence studies, 10 articles satisfied the eligibility criteria. Overall, there was a reduction of mean tinnitus score. There was a decrease in tinnitus score in 25% to 72%, and a total suppression of tinnitus after implantation was reported in 8% to 45% of patients. Tinnitus was stable in 0% to 36% of patients, and increase of tinnitus occurred in 0% to 25%. Tinnitus induction rates in the patients without preoperative tinnitus varied from 0% to 10%. CONCLUSIONS: There are no high level of evidence studies concerning cochlear implantation and the effect on tinnitus. Overall, current literature shows that there is a decrease of mean tinnitus questionnaire score after unilateral cochlear implantation. However, there is also a chance of increasing burden of existing tinnitus, and the induction of tinnitus is reported. LEVEL OF EVIDENCE: NA.