Totally implantable hearing system: Five-year hearing results.

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Audiology

Background:

• Sensorineural hearing loss affects millions globally, necessitating advanced audiological solutions.
• Traditional hearing aids offer some benefit but may not meet all patient needs.
• Totally implantable hearing systems represent a novel approach to hearing rehabilitation.

Purpose of the Study:

• To evaluate long-term hearing outcomes of a totally implantable hearing system.
• To compare the implant's performance against unaided and traditional hearing aid conditions.
• To assess the safety and adverse event profile of the implant system over five years.

Main Methods:

• A prospective, nonrandomized, multicenter study followed 49 subjects with mild to severe sensorineural hearing loss for five years.
• Primary endpoints included speech reception threshold (SRT) and word recognition scores (WRS50s).
• Secondary endpoints included WRSs, Abbreviated Profile of Hearing Aid Benefit (APHAB) scores, and safety monitoring (ADEs/SADEs).

Main Results:

• The implant demonstrated significant improvements in SRT and WRS compared to baseline aided conditions at all annual follow-ups.
• Word recognition scores improved by 17% at the 5-year mark, and APHAB scores showed consistent benefits.
• Three Serious Adverse Device Effects (SADEs) and 15 Adverse Device Effects (ADEs) were reported; bone conduction scores increased by 3.7 dB.

Conclusions:

• The totally implantable hearing system provided favorable and sustained hearing outcomes over five years compared to conventional hearing aids.
• The implant system was determined to be safe for long-term use in the study population.
• This technology offers a promising alternative for managing sensorineural hearing loss.