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Tag: FDA approval

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FDA Grants Accelerated Approval to Otarmeni Gene Therapy for OTOF-Related Hearing Loss

FDA Grants Accelerated Approval to Otarmeni Gene Therapy for OTOF-Related Hearing Loss

In a pivotal trial, 42% of participants achieved normal hearing using the gene therapy indicated for pediatric and adult patients with severe-to-profound hearing loss due to biallelic OTOF gene variants.

  • FDA Approves Med-El Cochlear Implant for Children 7 Months and Older

  • FDA Approves Clotic for Otomycosis Treatment

  • Envoy Medical Receives FDA Approval to Expand Acclaim Clinical Trial

  • Cochlear Launches Smart Cochlear Implant System

  • FDA Approves Sonnet 3 Audio Processor for Med-El Cochlear Implants

  • FDA Expands Med-El Cochlear Implant Indications

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FDA Authorizes First OTC Hearing Aid Software

FDA Authorizes First OTC Hearing Aid Software

The FDA authorized Apple's Hearing Aid Feature, the first over-the-counter (OTC) hearing aid software for use with compatible AirPods Pro.

  • Growth in Cochlear Implant Market Driven by Increased Awareness, FDA Approvals

    Growth in Cochlear Implant Market Driven by Increased Awareness, FDA Approvals

  • Oticon’s Sentio System Gets U.S. FDA Clearance

    Oticon’s Sentio System Gets U.S. FDA Clearance

  • Advanced Bionics Expands Cochlear Implant Tech Offering

    Advanced Bionics Expands Cochlear Implant Tech Offering

  • Soundwave Hearing Announces FDA Clearance for its Self-Fitting OTC Hearing Aid

    Soundwave Hearing Announces FDA Clearance for its Self-Fitting OTC Hearing Aid

  • Cochlear Nucleus 8 Sound Processor Receives FDA Approval

    Cochlear Nucleus 8 Sound Processor Receives FDA Approval

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