Isolated Second Implant Adaptation Period in Sequential Cochlear Implantation in Adults.

OBJECTIVE: To determine if depriving the use of the first cochlear implant (CI1) impacts adaptation to a sequential implant (CI2). STUDY DESIGN: Prospective cohort. SETTING: Academic center. PATIENTS: Sixteen unilateral cochlear implant recipients undergoing contralateral implantation (sequential bilateral) were matched according to age, etiology, duration of deafness, device age, and delay between implants. INTERVENTION: During a 4-week adaptation period after CI2 activation, patients underwent deprivation of CI1 or were permitted continued use of it. MAIN OUTCOME MEASURES: Speech perception scores and subjective quality of life outcomes before CI2 and at 1, 3, 6, and 12-months following activation. RESULTS: Maximal CI2 speech perception scores in quiet were achieved by 1-month postactivation for the "deprivation" group (71.3% for hearing in noise test [HINT], p = 0.767 for change beyond 1-mo) compared with 6-months for the "continued use" group (67.9% for HINT, p = 0.064 for change beyond 6-mo). The "deprivation" group experienced a temporary drop in CI1 scores (67.9% for HINT in quiet at 1-mo versus 78.4% pre-CI2, p = 0.009) recovering to 77.3% by 3-months; unchanged from baseline levels (p = 1.0). A binaural advantage over the better hearing ear was present for HINT sentences with noise (72.4% versus 58.8% for "deprivation", p = 0.001; 71.5% versus 52.7% for "continued use," p = 0.01). Missing data precluded a meaningful analysis of subjective quality of life outcome scales. CONCLUSION: Bilateral cochlear implantation improves speech perception compared with one implant. A period of deprivation from CI1 shortens time to maximum speech perception by CI2 without long-term consequences on the performance of CI1.

Depth of Cochlear Implant Array Within the Cochlea and Performance Outcome.

OBJECTIVE: To evaluate whether the depth of cochlear implant array within the cochlea affects performance outcomes 1 year following cochlear implantation. METHODS: A retrospective case review of 120 patients who were implanted with the Advanced Bionics HiFocus 1J. Post-implantation plain-radiographs were retrospectively reviewed, and the depth of insertion was measured in degrees from the round window to the electrode tip. Correlation between the depth of insertion and 1-year post-activation Hearing in Noise Test (HINT) scores was analyzed. Intrascala position was not assessed. RESULTS: Depth of electrode insertion ranged from 180° to 720°, and HINT scores ranged from 0% to 100%. A Mann-Whitney U test demonstrated significantly improved 1-year post-activation HINT scores in patients with an insertion depth of 360° or more in comparison with patients with insertion depth of less than 360° (81% vs 61%, P = .048). Patients with 13 to 15 contacts within cochlear turns performed as well as patients with full insertion of all 16 contacts, while patients with only 12 contacts performed poorly. CONCLUSIONS: Insertion depth of the AB HiFocus 1J electrode of less than 360° is associated with reduced 1-year post-activation HINT scores when compared with deeper insertions. Partial insertion of 13 active contacts or more led to similar results as full insertion.

Predictors of round window accessibility for adult cochlear implantation based on pre-operative CT scan: a prospective observational study.

BACKGROUND: Cochlear implantation has become a mainstream treatment option for patients with severe to profound sensorineural hearing loss. During cochlear implant, there are key surgical steps which are influenced by anatomical variations between each patient. The aim of this study is to determine if there are potential predictors of difficulties that may be encountered during the cortical mastoidectomy, facial recess approach and round window access in cochlear implant surgery based upon pre-operative temporal bone CT scan. METHODS: Fifty seven patients undergoing unilateral cochlear implantation were analyzed. Difficulty with 1) cortical mastoidectomy, 2) facial recess approach, and 3) round window access were scored intra-operatively by the surgeon in a blinded fashion (1 = "easy", 2 = "moderate", 3 = "difficult"). Pre-operative temporal bone CT scans were analyzed for 1) degree of mastoid aeration; 2) location of the sigmoid sinus; 3) height of the tegmen; 4) the presence of air cells in the facial recess, and 5) degree of round window bony overhang. RESULTS: Poor mastoid aeration and lower tegmen position, but not the location of sigmoid sinus, are associated with greater difficulty with the cortical mastoidectomy. Presence of an air cell around the facial nerve was predictive of easier facial recess access. However, the degree of round window bony overhang was not predictive of difficulty associated with round window access. CONCLUSION: Certain parameters on the pre-operative temporal bone CT scan may be useful in predicting potential difficulties encountered during the key steps involved in cochlear implant surgery.

The role of a new contralateral routing of signal microphone in established unilateral cochlear implant recipients.

OBJECTIVES/HYPOTHESIS: To investigate whether a contralateral routing of signal (CROS) microphone combined with a unilateral cochlear implant (CI) results in hearing improvement after a prolonged trial period. STUDY DESIGN: A prospective experimental trial was undertaken on a group of 10 postlingually deafened adults who are experienced CI users. METHODS: Participants completed audiometric testing and validated questionnaires with their unilateral CI alone, followed by addition of a CROS microphone (CI-CROS). This was worn daily for the 2-week trial, after which hearing performance was reevaluated using the same measures. Objective tests included AzBio sentences in quiet and noise and consonant-vowel nucleus-consonant (CNC) words. Subjective measures included the Abbreviated Profile of Hearing Aid Benefit (APHAB); Speech, Spatial, Qualities of Hearing Index (SSQ); Hearing Implant Sound Quality Index; an institutional questionnaire; and a daily log sheet. RESULTS: There is statistically significant enhanced speech discrimination with the CI-CROS when speech is presented on the CROS side. However, scores are markedly diminished when background noise is introduced, particularly to the CROS side. Subjective results indicate lower satisfaction scores for the global and ease of communication subdomains of the APHAB with the CI-CROS, but increased scores on the spatial hearing subdomain of the SSQ (P < 0.05). CONCLUSION: The CI-CROS provides significant benefit in certain situations, particularly speech recognition in quiet. CI-CROS performance with background noise is poor, leading to low satisfaction scores. Further refinement of the device may yield a useful tool for unilateral CI users in the future.

Cochlear implantation in patients with chronic suppurative otitis media.

OBJECTIVE: To determine the safety, efficacy, and outcomes of cochlear implantation in patients with chronic suppurative otitis media (CSOM). STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center with large cochlear implant program. PATIENTS: Nineteen patients with CSOM who underwent cochlear implantation were identified. Case history, timing of surgical procedures, complications, infections, and postimplant audiometric scores (Hearing in Noise Test [HINT], City University of New York Sentences [CUNY], and Central Institute for the Deaf Sentences [CID]) were evaluated. MAIN OUTCOME MEASURES: Rates of postoperative infections and complications as well as postimplant auditory performance. RESULTS: Twelve patients underwent a staged procedure involving canal wall down mastoidectomy or radical revision mastoidectomy with middle ear and mastoid obliteration and closure of the external auditory canal followed by cochlear implantation approximately 5 months later. Seven patients were implanted in a single procedure. There were no infections or medical complications after implantation. On average, patients had excellent audiometric scores at 1 year postimplantation (mean sentence test, 79%; SD, 14), and these scores were comparable to our general population (mean sentence test, 71%; SD, 32). CONCLUSION: Cochlear implant patients with CSOM have no increased risk of postoperative infections or complications. These patients have excellent outcomes with audiometric scores comparable to the general cochlear implant population. Cochlear implantation is a safe and effective treatment for patients with profound hearing loss secondary to CSOM.

A late recognition of tapia syndrome: a case report and literature review.

Tapia syndrome is characterized by concurrent paralysis of the recurrent laryngeal and hypoglossal nerves. The mechanism is associated with airway manipulation in 70% of patients and is attributed to compression or stretching of these nerves. Diagnosis is based on recognition of the concurrent paralyses and investigations to exclude central or vascular causes. Treatment is supportive, with emphasis on empiric corticosteroids and dysphagia therapy. Recovery is excellent in 30% of patients, incomplete in 39% of patients, and none in over 26% of patients. A case of a 48-year-old woman is described, who was diagnosed with Tapia syndrome 3 years after the suspected injury.

Dexamethasone uptake in the murine organ of Corti with transtympanic versus systemic administration.

OBJECTIVE: To investigate glucocorticoid uptake in auditory hair cells following transtympanic versus systemic administration of dexamethasone. STUDY DESIGN: Controlled experimental study. SETTING: Translational science experimental laboratory. METHODS: Swiss-Webster mice were injected with dexamethasone via transtympanic or systemic administration. At 1, 6, or 12 hours post-injection the temporal bones were harvested. After cryosectioning, immunohistochemical staining was performed using an antibody for dexamethasone. RESULTS: Dexamethasone labelling was greatest at 1 hour. Inner hair cells demonstrated much higher steroid uptake than outer hair cells. Both transtympanic injection and high-dose systemic administration resulted in strong dexamethasone labelling of hair cells, and a decreasing basal-to-apical gradient of hair cell fluorescence intensity was observed. Systemically delivered dexamethasone was rapidly eliminated from the inner ear, demonstrating mild labelling after 6 hours and none after 12 hours. In contrast, the mice receiving transtympanic injection had persistent moderate intensity fluorescence at 6 and 12 hours post-injection. CONCLUSION: There is similar uptake of dexamethasone by auditory hair cells after transtympanic and high-dose systemic delivery. Novel findings include the presence of a decreasing basal-apical gradient of steroid uptake, and demonstration of greater affinity of inner hair cells for dexamethasone compared to outer hair cells. In this animal model transtympanic injection resulted in prolonged steroid uptake. These findings help further our understanding of the pharmacokinetics of steroids in the cochlea, with a focus on auditory hair cells.

Facial nerve prognostication in vestibular schwannoma surgery: the concept of percent maximum and its predictability.

OBJECTIVES/HYPOTHESIS: To evaluate percent maximum as an intraoperative facial nerve measurement for the long-term prognostication of vestibular schwannoma surgery. STUDY DESIGN: Prospective cohort study. METHODS: Evoked amplitude responses to varying levels of stimulus intensity at the nerve root were compared to their supramaximal responses (Mmax) as a percentage, that is, percent maximum. Response charts were constructed for each of the levels of stimulus intensity between 0.05 to 0.3 mA, vis-à-vis facial nerve outcome at 1 year, to establish sensitivities, specificities, and positive predictive values. Logistic regression analyses were used to determine the impact of sex, age, tumor size, and historically defined response parameter on outcomes. RESULTS: Seventy-eight patients who underwent vestibular schwannoma surgeries between 2005 and 2010 were studied. The positive predictive value (PPV) of a good facial nerve outcome, defined as House-Brackmann (HB) I-II, increases with percent maximum responses. A 90% PPV could be established when the response amplitude was 50% or greater compared to Mmax. Long-term prognostication appeared best at a higher stimulus level of 0.3 mA. Age and sex did not have an impact on outcome, but tumor size did; with each centimeter increase in tumor size, patients were 105% more likely to have a poor outcome (HB III-VI). If the response parameter "≥240 µV at 0.05 mA" was not present, there was a trend toward poor outcome. CONCLUSIONS: Percent maximum is a valid intraoperative monitoring measure to prognosticate long-term facial nerve outcome. It should be considered a complementary method of monitoring when evoked responses do not conform to conventional predictors. LEVEL OF EVIDENCE: 4.

Results with cochlear implantation in adults with speech recognition scores exceeding current criteria.

OBJECTIVES: The primary purpose of this study was to evaluate a group of postlingually deafened adults, whose aided speech recognition exceeded commonly accepted candidacy criteria for implantation. The study aimed to define performance and qualitative outcomes of cochlear implants in these individuals compared with their optimally fitted hearing aid(s). STUDY DESIGN: Retrospective case series. SETTING: Tertiary referral center. PATIENTS: All postlingually deafened subjects (N = 27), who were unsuccessful hearing aid users implanted between 2000 and 2010 with a preimplantation Hearing in Noise Test (HINT) score of 60% or more were included. INTERVENTION: We compared patients' preoperative performance (HINT score) with hearing aids to postoperative performance with the cochlear implant after 12 months of device use. In addition, the Hearing Handicap Inventory questionnaire was used to quantify the hearing-related handicap change perceived after the implantation. RESULTS: The study group demonstrated significant postoperative improvement on all outcome measures; most notably, the mean HINT score improved from 68.4% (standard deviation, 8.3) to 91.9% (standard deviation, 9.7). Additionally, there was a significant improvement in hearing-related handicap perceived by all patients. CONCLUSION: The envelope of implantation candidacy criteria continues to expand as shown by this study's cohort. Patient satisfaction and speech recognition results are very encouraging in support of treating those who currently perform at a level above the conventional candidacy threshold but struggle with optimally fitted hearing aids.

Telephone use and the factors influencing it among cochlear implant patients.

OBJECTIVE: To investigate telephone use in cochlear implant patients and to determine factors most likely to influence telephone use. METHODS: Surveys were mailed to 504 cochlear implant patients treated at Sunnybrook Health Sciences Hospital. RESULTS: Two hundred four patients returned surveys (49%), 87% were classified as telephone users. No differences were found in age, pre-implant hearing characteristics, and the majority of post-implant behaviors. Education and post-implant sound perception scores were found to be significantly different (P < 0.05) between telephone users and non-users. DISCUSSION: Telephone use among cochlear implant patients shows a positive increase compared to previous studies. In addition, we find that higher attained education and post-implant hearing scores to be independently correlated to telephone use.

The effects of unilateral cochlear implantation on the tinnitus handicap inventory and the influence on quality of life.

OBJECTIVES/HYPOTHESIS: Cochlear implantation is now the standard of care in patients with significant sensorineural hearing loss. It is well known that patients with severe hearing loss also experience disabling tinnitus. The purpose of this study was to assess the effects of cochlear implants on the perception of tinnitus using the Tinnitus Handicap Inventory (THI). STUDY DESIGN: Prospective, longitudinal study of 142 cochlear implant patients. METHODS: The THI was administered to 142 patients pre- and postimplantation. Outcome measures were obtained 12 months after the implantation. Secondary analyses to examine the correlation between changes in THI scores and outcome measures such as Hearing Handicap Inventory, Hearing in Noise Test (HINT), and short-form 36 (SF-36) quality-of-life scores were performed. RESULTS: Patients demonstrated statistically significant reduction of the THI scores including its subscales (P < .001). Prior to implantation, 37% of patients described their tinnitus as moderate to severe. Postoperatively, this percentage decreased to 10%. Cochlear implantation resulted in complete tinnitus suppression in 37% and tinnitus reduction in another 29% of patients. THI scores significantly correlated with three domains of the SF-36 quality-of-life questionnaire, namely social, emotional, and general health domains. CONCLUSIONS: Cochlear implants have a significant suppressive effect on tinnitus in 66% of implant users. Although the reduction in the subjectively perceived tinnitus was statistically significant, it did not correlate with HINT; however, it did correlate with three quality-of-life domains, more significantly for those whose pretreatment conditions were moderate or worse.

Cochlear implantation in patients with bilateral severe sensorineural hearing loss after major blunt head trauma.

OBJECTIVE: To highlight issues that impact on cochlear implant candidacy and performance in individuals who have severe bilateral sensorineural hearing loss after major blunt head trauma. STUDY DESIGN: Retrospective case review. SETTING: Tertiary level neurotology center. PATIENTS: Twenty-five patients treated at our institution for severe hearing loss after blunt head trauma INTERVENTION: Assessment of cochlear implant candidacy criteria and postimplant outcomes in patients presenting with severe hearing loss after major blunt head trauma MAIN OUTCOME MEASURES: Cause of injury, pure tone audiology, open set speech perception (preimplant and postimplant), promontory stimulation, and imaging results. RESULTS: Of the 25 patients with severe hearing loss, 11 ultimately underwent cochlear implantation. Fall from a height was the most common cause of injury. Five patients experienced bilateral temporal bone fractures. Seventeen patients satisfied candidacy criteria for implantation. For those patients who did undergo cochlear implantation, the mean postimplant open set speech recognition score was 71. Issues related to cochlear implant candidacy and outcomes for implantation will be discussed. CONCLUSION: Severe hearing loss after major blunt head trauma presents a number of unique clinical challenges. A significant number of these patients are not suitable for cochlear implantation for a variety of reasons. Clinicians working in the area of cochlear implantation should be aware of the various problems that can impact on effective cochlear implantation in such patients.

Postlingually deaf adults of all ages derive equal benefits from unilateral multichannel cochlear implant.

BACKGROUND: Controversy still exists regarding the impact of age on speech recognition following cochlear implant in postlingually deaf adults. In some studies elderly recipients did not perform as well as younger patients on standard speech recognition tests. Furthermore, previous studies have shown that cochlear implantation improves quality of life, as measured by self-administered questionnaires, but the sample sizes of these studies have been relatively small, thus making age stratification a challenge. PURPOSE: The primary objective was to assess whether the age at which a patient receives a unilateral cochlear implant affects improvements in speech recognition scores and perceived quality of life. A secondary objective was to determine whether preoperative use of hearing aids correlates with improvement in speech recognition and perceived quality of life after cochlear implantation. RESEARCH DESIGN: A retrospective study in a tertiary referral center. PATIENTS: A total of 161 postlingually deaf adults, who were divided based on age (<50, 50-65, >65) and on prior hearing aid(s) use. INTERVENTION: All patients received a unilateral multichannel cochlear implant. DATA COLLECTION AND ANALYSIS: Speech recognition was quantified by percent correct scores on the Hearing in Noise Test sentences delivered in a quiet setting only (HINT%), and quality of life was quantified by the Hearing Handicap Inventory (HHI) before and 1 yr after cochlear implantation. RESULTS: Speech recognition, as measured by HINT%, improved significantly and to similar extents in all three age groups following cochlear implantation. Similarly, quality of life as quantified by HHI improved markedly and to similar extents in all age groups. Whether hearing aids were used pre-implant, or whether the cochlear implant (CI) was implanted on the same side or contralateral to the hearing aid side, had no substantial effect on the patients' performances on either speech recognition or quality of life. Moreover, there were no statistically significant correlations between pre-implant speech recognition scores and pre-implant quality of life scores or between postimplant speech recognition scores and postimplant quality of life scores. CONCLUSION: The findings of the present study demonstrate that cochlear implantation improves HINT% and HHI scores to similar extents across all age groups. This finding suggests that elderly patients may derive speech recognition and quality of life benefits similar to those of younger patients and that age should not be an essential factor in the determination of CI candidacy. Furthermore, prior use of a hearing aid, and its location in relation to the cochlear implant, does not influence the extent of improvement in speech recognition or quality of life measurements following cochlear implantation.

When do we choose the 'better balance' ear for cochlear implants?

OBJECTIVES: In cochlear implant planning, the ear with poorer vestibular function, as determined through electronystagmography (ENG), is often selected as the site for implantation since surgery carries a low risk of iatrogenic labyrinthine injury. We sought to determine reasons for placing a cochlear implant in the 'better balance' ear. METHODS: A retrospective cohort study of patients implanted with a cochlear implant at a tertiary care center from 1984 to June 2009 was performed. Based on ENG results, patients with asymmetric caloric reduction were identified. Of these patients, those who were implanted in the 'better balance' ear were selected for chart review. The charts were reviewed to determine rationale for ear selection. RESULTS: Of the 724 cochlear implant patients implanted from 1984 to June 2009, ENG tests demonstrated that 130 (18%) had asymmetric abnormal responses. Thirty five (27%) of the patients with asymmetric abnormal responses were implanted in the 'better balance' ear. Review of these 35 patient charts revealed that reasons for selection of the 'better balance' ear fell into four categories: anatomical contraindications, attempting to attain binaural hearing, avoiding implantation of an ear with marked auditory deprivation, and patient preference. DISCUSSION: Based on our current practice, we have identified four situations in which patients were implanted in the 'better balance' ear, and subsequently developed an algorithm to aid surgeons in side selection for cochlear implantation. Further study and validation of this algorithm is recommended.

Improved hearing with cochlear implantation in Fabry's disease.

OBJECTIVE: To describe our center's experience with cochlear implantation in patients suffering from Fabry's disease, an inherited mutation resulting in an alpha-galactosidase A enzyme deficiency. CLINICAL PRESENTATION: Case report of two patients aged 49 and 59 at implant, with genetically confirmed Fabry's disease and progressive hearing loss. INTERVENTION: Surgical implantation of Clarion (Advanced Bionics) and Nucleus Freedom (Cochlear) cochlear implants. CONCLUSION: Cochlear implantation improves hearing discrimination by 60 points on the HINT scale. This suggests that cochlear implantation is a safe and effective intervention that improves hearing discrimination in patients suffering from Fabry's disease.

Cochlear implantation in patients with autoimmune inner ear disease including cogan syndrome: a comparison with age- and sex-matched controls.

OBJECTIVES/HYPOTHESIS: Evaluate the characteristics and outcomes of patients with autoimmune inner ear disease (AIED) who have undergone cochlear implantation (CI) and compare post-CI performance in AIED to matched controls. STUDY DESIGN: Retrospective case control study. METHODS: Study cohort was comprised of 25 adult implantees (AIED [n = 18], Cogan syndrome [n = 7]). The AIED group was defined by rapidly progressive bilateral sensorineural hearing loss leading to unusable hearing within weeks to months. Patients with Cogan syndrome, the archetypal inner ear autoimmune disease, were also examined and used for within-cohort comparison. Clinical and operative records were reviewed. Post-CI performance was assessed using open-set sentence tests. Age- and sex-matched individuals deafened by other postlingual causes were used as controls. RESULTS: Of 25 patients, 24 had uneventful, full electrode insertions. One AIED patient had partial insertion due to cochlear ossification and did not achieve open-set speech perception post-CI. Mean open-set sentence scores for study patients with uneventful insertions were 92.8%, 97.3%, and 96.4% at 6 months, 1 year, and ≥ 2 years, respectively. Compared to matched controls, patients deafened by autoimmune causes had significantly higher post-CI performance at all postoperative test intervals (P < .05). There was no significant difference in postimplantation performance between Cogan syndrome and AIED patients. CONCLUSIONS: To our knowledge this was the largest study of cochlear implantation in AIED and Cogan syndrome patients. In our experience, both groups generally attained high levels of post-CI speech perception and performed above average. Cochlear ossification affecting implantation in Cogan syndrome patients was not observed in our series, contrary to some reports.

Medical and noninvasive therapy for Meniere's disease.

Nonoperative therapy continues to be the mainstay of treatment of patients suffering from Meniere disease. Despite extensive research, the exact pathogenesis of Meniere disease remains elusive. The poorly understood nature of this condition has made it nearly impossible to develop treatments that are curative. Most modern treatments are aimed at controlling symptoms. This article reviews the various nonoperative treatments that have been used to treat Meniere disease historically as well as outlining the authors' clinical treatment paradigm.

Prevalence of Connexin 26 (GJB2) and Pendred (SLC26A4) mutations in a population of adult cochlear implant candidates.

OBJECTIVE: To assess the prevalence of Connexin 26 (GJB2), Connexin 30 (GJB6), and Pendred (SLC26A4) mutations in a population of adult cochlear implant patients with a history of either early idiopathic or hereditary progressive sensorineural deafness. BACKGROUND: Significant efforts have been applied in defining the epidemiology of Connexin 26 (GJB2)-associated hearing impairment in the pediatric population, yet the issue remains ambiguous for adult patients. Causation is important in this population because there are implications to prognosis, risk of associated medical manifestations, and for genetic counseling purposes. PATIENTS: Adult patients meeting criteria for cochlear implantation with early-onset hearing loss assessed at an adult cochlear implant center from November 2007 to April 2009. INTERVENTION: Genomic DNA samples from whole blood were tested with bidirectional sequence analysis for mutations in the coding region of the GJB2 and SLC26A4 genes and tested for large deletions of the GJB6 gene. RESULTS: Fifty-seven patients were analyzed for GJB2 mutations. Eight patients (14%) were found to have GJB2-related hearing impairment; 5 patients were homozygous for the c.35delG mutation (genotype c.35delG/c.35delG), and 3 additional patients were compound heterozygotes with 2 different GJB2 mutations. Of these 8 patients with GJB2-related hearing impairment, 3 had serviceable hearing into their teenage years. One additional patient had 1 GJB2 variant (p.Met195Ile, heterozygous). None had GJB6 mutations. Of the 57 patients, 30 were also analyzed for SLC26A4 mutations. Three of these patients were compound heterozygotes for disease-causing SLC26A4 mutations, confirming SLC26A4-related hearing impairment. Three additional patients were found to have a single variant in SLC26A4. CONCLUSION: The prevalence of GJB2- and SLC26A4-related hearing impairment in an adult population with early-onset severe sensorineural hearing loss is significant, suggesting the need for routine assessment for genetic etiologies in this group. We also note 3 individuals with causal connexin 26 mutations with subjective serviceable hearing into adolescence in our cohort.

Sunnybrook facial grading system: reliability and criteria for grading.

OBJECTIVES/HYPOTHESIS: In clinical research, which is distinctly quantitative and rigidly fixed to a written protocol, the need for precision is great, especially when multicenter trials are planned. The Sunnybrook Facial Grading System (SB) is a well-established tool for assessing facial movement outcomes; however, some ambiguities do arise. The purpose of this study was to construct specific grading criteria and to test the intra-rater and inter-rater reliability before and after the use of these criteria. The hypothesis was that even in naïve observers, specific criteria improve reliability. STUDY DESIGN: Prospective test of hypothesis. METHODS: Facial video recordings of 30 subjects with facial paralysis were randomly presented to two naïve raters in four trials; trials 1 and 2 using the SB system in the usual manner, and trials 3 and 4 using specific grading criteria for the SB system. RESULTS: The SB system was reliable, even with naïve raters, having an intraclass correlation coefficient (ICC) of 0.890 between raters; this was improved with the use of specific grading criteria to 0.927. Additionally, variability of the SB composite scores was greatest in the midrange of scores and was predominantly seen during voluntary movement of brow rising and lip puckering. CONCLUSIONS: To our knowledge, this is the first report of specific criteria for completing the SB system. It is also the first in-depth description of the location within the system in which the majority of variances occur.