Long-Term Safety and Quality of Life after Vibroplasty in Sensorineural Hearing Loss: Short/Long Incus Process Coupler.

OBJECTIVE: The study shows the long-term effectiveness, safety, and quality of life after Vibrant Soundbridge (VSB) implantation in sensorineural hearing loss (SNHL) using the short process coupler (SP) or the long process coupler (LP). METHODS: This retrospective study evaluated 77 VSB cases. Follow-up (F/U) time-dependent objective measurements (audiological outcomes), subjective data collection (quality-of-life questionnaire), and safety measures are presented. RESULTS: Sixty-two ears were included in the analysis with up to 116 months of postsurgical F/U data (mean 32.15 ± 37.97 months LP and SP coupler). Fifty-three ears (13 bilateral cases) received the LP coupler and 9 subjects the SP coupler. The post-operative bone conduction thresholds remained stable and, in both groups, <10 dB. The benefit in word recognition scores measured at 65 dB SPL and 80 dB SPL showed no significant difference between the couplers (p = 0.559 and p = 0.088, respectively). The functional gain was not significantly different (p > 0.05) with a mean of 20.91 ± 9.77 and 17.19 ± 5.75 for LP and SP coupler, respectively. The utility score deciphered from the Assessment of Quality-of-life Questionnaire-8 dimensions revealed a mean score of 0.75 ± 0.16 which is not significantly different to the age- and sex-matched healthy control group with 0.81 ± 0.02 (p = 0.3547). CONCLUSION: The Incus Vibroplasty utilizing both couplers is a safe and effective method to treat mild-to-severe SNHL. Both fixation methods of the floating mass transducer exhibit good clinical and audiological outcomes with high patient quality of life. The SP coupling method can be a good alternative when the long process is anatomically inaccessible, or the approach is limited due to anatomical reasons.

Surgical Experience and Early Audiological Outcomes With New Active Transcutaneous Bone Conduction Implant.

OBJECTIVES: Our objective was to report the very first surgical experiences, audiologic benefits, and satisfaction with the new active transcutaneous bone conduction implant, generation 602 (BCI602), in patients with mixed/conductive hearing loss (M/CHL) and single-sided deafness. METHODS: A retrospective chart review from patients who underwent BCI602 surgery was performed. RESULTS: Twelve subjects were implanted (mean age 33.17 ±â€Š21.67 yrs). Mean surgery time was 29.89 ±â€Š8.59 minutes, with the longest being a difficult passive-BCI explantation due to excessive osseointegration. No surgical nor post-surgical complications occurred. No pre-operative surgical planning for device placement was necessary, no BCI-lifts were used and complete transmastoid implantation was possible. The mean functional gain in the M/CHL cohort significantly increased after 3 months (ρ < .0001). The mean word recognition score (%) in quiet for the M/CHL group significantly improved at activation and 3 months post-surgery (ρ = .0002; ρ < .0001). At the 3 months follow-up the subjects reported high satisfaction with the device accompanied with a mean wearing time of 10.13 hours per day (range 18-6 h/d) resulting in a reported battery change of every 8.29 ±â€Š0.49 days. CONCLUSIONS: These early results of the new BCI602 showed significantly improved audiological performance, no limitations during surgery (youngest subject 2 yrs at surgery), no prior surgical planning necessary, accompanied by high patient satisfaction and increased wearing time. Based on these results, the BCI602 can be highly recommended and especially for difficult anatomical and surgical cases and the given indication for children older than 5 years should probably be revaluated.Level of Evidence: Level 4.

Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window.

OBJECTIVE: The objective of the study was to demonstrate the long-term outcomes of patients implanted with the active middle ear implant (AMEI) Vibrant Soundbridge (VSB) through coupling the floating mass transducer (FMT) to the round window (RW). METHODS: This retrospective study evaluated the short- and long-term clinical performance (audiological outcomes) and safety (revisions/explantations) of the VSB coupled to the RW between 2013 and 2019 at the St. Pölten University Hospital, Austria. For the outcome analysis, the sample was divided into a short-term examination group followed up for less than 12 months (<12 months) and a long-term examination group followed up for more than 12 months (>12 months). Cumulative survival outcomes were separately analyzed for subjects with and without cholesteatoma. RESULTS: 46 patients with an average long-term follow-up period of 31.43 months (13-75 months) were investigated. Complications requiring revision surgery were reported in total in seven patients with cholesteatoma (15.2%) and none in subjects without cholesteatoma (0%). Residual hearing was not affected by VSB surgery. Word understanding on the Freiburger monosyllabic speech test improved significantly at 65 dB (P < .0001) and 80 dB (P < .0001), and these outcomes were stable for long-term follow up. CONCLUSION: The VSB coupled to the RW is a safe implantation method for patients with conductive or mixed hearing loss. Hearing improvement was stable for the long-term follow-up up to 74 months. The revision rates are directly related to the underlying pathology of cholesteatoma (with radical cavity); thus, this special cohort requires additional counseling on potential complications. LEVEL OF EVIDENCE: 4 (Case-series) Laryngoscope, 131:E1434-E1442, 2021.

Long-term Hearing Preservation in Electric Acoustic Cochlear Implant Candidates.

OBJECTIVES: To evaluate long-term stability and residual hearing preservation after cochlear implantation with electric acoustic stimulation (EAS). STUDY DESIGN: Retrospective chart-analysis. SETTING: University clinic. METHODS: Long- and short-term hearing preservation (HP) of 18 EAS subjects (21 ears) was evaluated. Short-term was defined as follow-ups less than 12 months after surgery versus long-term outcomes longer than 12 months postsurgery. RESULTS: Mean period of observation in the short-term group was 4 ±â€Š3.0 months (range 0-7). In the long-term group the mean follow-up was 28.4 ±â€Š15.0 months (range 12-58). Full insertion was possible in all 18 implanted subjects. In the short-term group, complete HP was achieved in 50%, partial HP in 33.3%, and minimal HP in 8.3% of the investigated subjects. One subject lost hearing completely. In the long-term group, complete HP was achieved in 50%, partial HP was observed in 40%, and minimal HP in 10% of the ears. No subject lost hearing completely. Subjects using EAS showed better word recognition scores after surgery (mean at 65 dB 55.3 ±â€Š18.4; mean at 80 dB 68.1 ±â€Š12.2) than subjects using electric stimulation only (mean at 65 dB 38.3 ±â€Š18.1; mean at 80 dB 60.0 ±â€Š16.4) with nonfunctional low-frequency hearing. CONCLUSION: The study confirms that hearing can be preserved to a large extent. As a result, most subjects benefitted from EAS. Subjects with postoperative functional low-frequency hearing showed greater benefit in word speech tests. Furthermore, the outcomes show that EAS implantation is a safe, effective, and most importantly stable treatment option (longest follow-up with 58 mo).