Star Metro - Advanced Bionics Announces FDA Approval of Expanded Cochlear Implant Inclusion Criteria for Patients with Single-Sided Deafness and Asymmetric Hearing Loss

VALENCIA, CA / ACCESS Newswire / July 28, 2026 / 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. adults living with single-sided deafness (SSD),¹ and cochlear implant utilization among individuals meeting expanded candidacy criteria for SSD or asymmetric hearing loss (AHL) estimated at only 2.1%,² the unmet need and opportunity to reach appropriate candidates remains substantial.

"This expanded candidacy marks an important step forward for patients who may previously have fallen outside cochlear implant indications," said Alistair Simpson, president of Advanced Bionics. "By broadening access for people with single-sided deafness and asymmetric hearing loss, we can help more clinicians recommend AB cochlear implants for appropriate candidates and help more patients achieve their best hearing."

For clinicians, the expanded criteria may help simplify cochlear implant candidacy discussions and improve patient satisfaction by reducing the number of patients who fall outside indications and minimizing the additional testing often needed to demonstrate listening challenges.

For candidates, it extends access to a cochlear implant platform designed to deliver a connected hearing experience, seamless integration with Phonak technology, and ease of use in everyday, real-world situations.

Expanded FDA candidacy INCLUSION criteria

Single-sided deafness: Adults (18+ years) with a pure-tone average of 80 dB HL/children (5-17) with a pure-tone average of 90 dB HL or greater in the poorer ear, and less than 30 dB HL in the better ear.

Asymmetric hearing loss: Adults with a pure-tone average of 80 dB HL/children with a pure-tone average of 90 dB HL or greater in the poorer ear, and better-hearing ear has a pure-tone average greater than 30 dB HL, with at least a 15 dB difference between ears.

Audiometric criteria: Adults qualify if they have a CNC word recognition score of less than or equal to 20%. Children qualify if they have a speech-testing score of less than or equal to 5% on a developmentally appropriate monosyllabic word list.

References:

1. Kay-Rivest E, Irace AL, Golub JS, Svirsky MA. Prevalence of Single-Sided Deafness in the United States. Laryngoscope. 2022 Aug;132(8):1652-1656. doi: 10.1002/lary.29941. Epub 2021 Nov 10. PMID: 34757636; PMCID: PMC9085960.

2. Nassiri AM, Sorkin DL, Carlson ML. Current Estimates of Cochlear Implant Utilization in the United States. Otol Neurotol. 2022 Jun 1;43(5):e558-e562. doi: 10.1097/MAO.0000000000003513. Epub 2022 Mar 8. PMID: 35261379.

For more information, please visit: www.advancedbionics.com

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About Advanced Bionics

Advanced Bionics is a global leader in developing hearing solutions for individuals with severe-to-profound hearing loss who no longer benefit from hearing aids. Founded in 1993 and a subsidiary of the Sonova Group since 2009, AB develops cutting-edge cochlear implant technology that allows recipients to hear their best. AB joined Phonak as part of the Sonova Group of companies and began a collaboration unlike any other in the industry. Since then, the innovation leaders in cochlear implants and hearing aids have continuously combined technologies to deliver new, unequalled hearing solutions.

With sales in more than 80 countries and a proven track record for developing high-performing, state-of-the-art products, AB's talented worldwide group of technologists and professionals are driven to engage with patients and professionals, work with integrity, and stay firmly committed to the best possible performance.

Media Relations contact:

Advanced Bionics LLC,
Email: [email protected]

SOURCE: Advanced Bionics LLC

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F.Leblanc--SMC