Totally Implantable Active Middle Ear Implant: Hearing and Safety Results in a Large Series

[Tigo]

Totally Implantable Active Middle Ear Implant: Hearing and Safety Results in a Large Series

Objectives
To evaluate hearing performance and safety measures in a large group of totally implantable active middle ear implant (AMEI) wearers.

Methods
Retrospective case review of 172 ears (166 patients) with sensorineural hearing loss undergoing implantation of a totally implantable AMEI. Pure‐tone air and bone thresholds, pure‐tone average, speech reception threshold (SRT), and word recognition scores (WRS) at phonetically balanced maximum and at 50 dB (WRS50) were assessed at baseline unaided, with a hearing aid (baseline aided [BLA]), with the implant at activation, and for best implant postoperative measurement. Adverse events were reviewed.

Results
Mean length of follow‐up was 35.7 months. Compared to unaided, the implant provided significant gain at all frequencies through 6 kHz. Amount of gain was significantly better with the implant than BLA at 1,500 and 2,000 Hz (P ≤ .001). Implant SRT was also significantly improved compared to BLA (29.9 dB vs. 38.5 dB, P ≤ .001). At a 50‐dB presentation level, WRS was significantly better with the implant than BLA (65.6% vs. 45.5%, P ≤ .001). Bone conduction thresholds were not affected by the implant. The most common adverse event was taste disturbance, which occurred in 39.1%. In subjects with preimplant tinnitus, 56.1% experienced resolution of their tinnitus. Revision surgery was required in 15.7%, and 4% were ultimately explanted.

Conclusion
The implant provided significant hearing benefit compared to unaided and to the subjects' own hearing aids in most test categories, with minimal adverse events. Many subjects experienced complete resolution of their tinnitus after implantation.

 

[Nick47]

Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study

Objective: To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD).

Study design: Prospective cohort study.

Setting: Tertiary referral hospitals.

Methods: This prospective multicenter study was conducted at 15 institutions nationwide. Thirty adult (aged ≥19 years) SSD patients were recruited. They underwent implantation of an active transcutaneous BCI device (Bonebridge BCI602). Objective outcomes included aided pure-tone thresholds, aided speech discrimination scores (SDSs), and the Hearing in Noise Test (HINT) and sound localization test results. The Bern Benefit in Single-Sided Deafness (BBSS) questionnaire, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and the Tinnitus Handicap Inventory (THI) were used to measure subjective benefits.

Results: The mean aided pure-tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a significant factor of subjective benefit (-11.643; 95% confidence interval: -21.946 to -1.340).

Conclusion: The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with long-term deafness.