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Advanced Bionics announced on July 26 that the FDA has approved expanded candidacy criteria for its cochlear implants, allowing more people with single-sided deafness and asymmetric hearing loss to qualify. Single-sided deafness refers to substantial hearing loss in one ear with typical hearing in the other. Asymmetric hearing loss refers to significantly different levels of hearing between the two ears.
Under the newly approved criteria, adults 18 and older with single-sided deafness qualify if they have a pure-tone average of 80 decibels or greater in the poorer ear and less than 30 decibels in the better ear. For children ages 5 to 17, the threshold in the poorer ear is 90 decibels or greater, with less than 30 decibels in the better ear. According to the company, the change is intended to help clinicians recommend cochlear implants for patients who previously fell outside the approved indications.
This expands the pool of people who may be eligible for a cochlear implant rather than changing the device itself. Candidacy for a cochlear implant is determined by a hearing healthcare provider based on individual evaluation.
Learn more here.
