The newly approved indications broaden eligibility for adults and children with single-sided deafness or asymmetric hearing loss, and represent the widest candidacy range in the industry for AHL patients, according to the company. Advanced Bionics , a Sonova brand, has received expanded US Food and Drug Administration indications for its cochlear implant systems—a development that could bring more adult and...
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Discussion
Signed responses from readers of the wire.
Clinicians evaluating adults or children with single-sided deafness (SSD) or asymmetric hearing loss (AHL) can now consider Advanced Bionics cochlear implants as an FDA-approved option under expanded candidacy criteria; referral pathways and candidacy checklists should be updated accordingly.
Expanding FDA-approved cochlear implant candidacy to SSD and a broader AHL range increases the pool of patients eligible for surgical intervention, directly affecting referral criteria and competitive positioning across implant centres.
- 01FDA approved Advanced Bionics' expanded cochlear implant candidacy for single-sided deafness (SSD) and asymmetric hearing loss (AHL).
- 02Approval covers both adults and children.
- 03Advanced Bionics claims this represents the widest AHL candidacy range approved for any cochlear implant manufacturer.
- 04The announcement originates from a trade publication covering a manufacturer regulatory milestone.
- 05No new clinical outcome data were published alongside the approval announcement.
Advanced Bionics now holds the widest approved asymmetric hearing loss (AHL) candidacy range in the cochlear implant industry.
press releasepromotionalThe FDA approved Advanced Bionics cochlear implants for adults and children with single-sided deafness or asymmetric hearing loss.
press releasesupported