Advanced Bionics achieves FDA approval for cochlear implants in single-sided deafness and asymmetric hearing loss

Advanced Bionics (Sonova)/HiRes Ultra 3D Cochlear Implant

Advanced Bionics announced FDA approval of expanded indications for HiRes Ultra 3D and Marvel to treat single-sided deafness and asymmetric hearing loss, significantly broadening the addressable patient population.

• Expanded SSD indications: adults (18+) ≥80 dB HL affected ear, <30 dB HL better ear; children ≥90 dB HL.
• AHL indications: ≥80 dB HL worse ear, >30 dB HL better ear, ≥15 dB difference between ears.
• Estimated 271,000-345,000 U.S. adults have SSD; only 2.1% of eligible patients use CI today.
• Approval applies to both HiRes Ultra 3D and Marvel systems.