Advanced Bionics Hires Ultra 3 D Ci

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. 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. By broadening access for people with single -sided deafness and asymmetric hearing loss, we can help more clinicians recommend AB cochlear implant s for appropriate candidates and help more patients achieve their best hearing.

Alistair Simpson, President of Advanced Bionics
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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.

For more information, please visit the Advanced Bionics website.

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.

SOURCE: Advanced Bionics

  • HearingTracker Staff