VALENCIA, CALIF — Advanced Bionics, a global leader in cochlear implant technology and a Sonova brand, today announced expanded U.S. Food and Drug Administration indications for its cochlear implant systems, giving more adult and pediatric patients with single-sided deafness or asymmetric hearing loss a clearer path to better hearing with cochlear implantation. With an estimated 271,000 to 345,000 U.S....
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Discussion
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Audiologists and cochlear implant teams should update their candidacy screening criteria: Advanced Bionics CI systems are now FDA-approved for adult and pediatric patients with single-sided deafness and asymmetric hearing loss, expanding the referral pool beyond traditional bilateral severe-to-profound loss.
This regulatory expansion meaningfully broadens the population eligible for cochlear implantation in the U.S., prompting clinics to revisit referral pathways and counseling protocols for SSD and AHL patients who were previously limited to non-implantable solutions.
- 01FDA expanded Advanced Bionics CI indications to include single-sided deafness (SSD) and asymmetric hearing loss (AHL).
- 02Expansion covers both adult and pediatric patient populations.
- 03Previously, CI candidacy was largely restricted to bilateral severe-to-profound sensorineural hearing loss.
- 04This is a regulatory (FDA approval) milestone, not a new clinical trial result.
- 05Clinicians should revisit referral and candidacy criteria to identify newly eligible patients.
The FDA expanded indications for Advanced Bionics cochlear implant systems to include adult and pediatric patients with SSD and AHL.
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