Author(s)
Darius Kohan, MD
Ilana Yellin, MD
Affiliation(s)
Lenox Hill Hospital/ MEETH - Northwell Health;
Abstract:
Objective: To assess surgery and hearing outcomes after implantation with most recent FDA approved active transcutaneous bone-anchored hearing devices.
Study Design: Retrospective cohort study.
Setting: Tertiary academic otology-neurotology practice including ambulatory surgery center.
Patients: Adults 18 or older with hearing loss meeting criteria for active transcutaneous bone-anchored auditory implants having failed non-surgical options from April 2019 to January 2024.
Interventions: Implantation of one of two active transcutaneous bone-anchored hearing devices.
Main Outcome Measures: Functional and effective gain in pure tone average (PTA4), qualitative patient satisfaction Abbreviated Profile of Hearing Aid Benefit (APHAB), dural or sigmoid sinus exposure/compression, use of lifts, implant location, surgical and postoperative complications.
Results: There were 52 patients implanted during the study period performed by the same surgeon/audiologist team. 23 patients met the study criteria. Ten patients had the Cochlear Osia OSI200 (Sidney, Australia) designated “IO,” 13 patients had the MED-EL BONEBRIDGE BCI 602 (Innsbruck, Austria) designated “IB.” 57% of study population chose IB. Overlapping etiologies for hearing loss included: cholesteatomas (52%), chronic suppurative otitis media (13%), single sided deafness (SSD) (17%), and otosclerosis (13%). All non-SSD patients had multiple prior surgeries. 17 procedures were performed concurrent with other otologic interventions. IB required lifts in 3 patients, dural/sigmoid sinus exposure/compression occurred in 3 patients, and 3 placements were retro sigmoid. The only complication involved IB trauma 3 weeks post-surgery requiring explant and reimplant a few months later. The overall effective/functional gain (EG/FG) for mixed/conductive hearing loss (M/CHL) was respectively 37dB/32dB and when separated by device, IB 40dB/35 dB, IO 33dB/28dB. For SSD overall effective/functional gain was 70dB/35dB. The percentage of maximum potential PTA4 gain was 49% for SSD and 88% for M/CHL regardless of device. Cosmetic issues of prominent implant profile occurred in 3 IO and 1 IB patients. All patients had measurable audiologic benefits from implants. APHAB global total benefit scores were +28 (+30 for M/CHL and +18 for SSD). Results for M/CHL were +24 for IB and +36 for IO. The Aversiveness score (AV) favored -25 IO to -16 IB.
Conclusions: Both IO and IB provide excellent auditory benefit (including high frequencies) in patients not amenable to aural rehabilitation with standard amplification. Surgical complications are very low. Devices size, MRI compatibility, finances, and connectivity determine patient choice of device. Effective/functional gain is slightly better for IB, and APHAB scores favor IO. Auditory outcomes are better in patients with M/CHL versus sensorineural deficits.
Professional Practice Gap & Educational Need: Challenges in constantly evolving technology on implantable active bone-conduction auditory devices relative to indications, applications, surgery, risks and audiologic benefits to be derived from different devices.
Learning Objective: 1. Understand indications for different active transcutaneous bone-anchored hearing devices. 2. Learn surgical techniques and risks associated with these devices. 3. Learn the audiologic benefit and patient satisfaction with these devices.
Desired Result: For otolaryngologist and audiologists to become familiar with the surgical and audiologic indications for active transcutaneous bone-conduction hearing implants (BCHI), to become familiar with the surgery associated with them and the risks involved, and to have realistic expectations on the audiologic benefits and limitations.
Level of Evidence: Level IV
Indicate IRB or IACUC: IRB # 22-0342 Approval of Hofstra Medical School, Northwell Health