FDA approvals and recalls

Hearing: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

Device recalls

7 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Implant, Cochlear

    Reason: Due to incorrect shelf-life expiration date.

    Z-2283-2026

  • Implant, Cochlear

    Reason: The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.

    Z-1950-2026

  • Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

    Reason: Three issues 1. Label error: The manufacturer information in the labeling is not correct, the manufacturer's name is mislabeled as "Developed by AcoSound," Correct should be "Manufactured by Hangzhou…

    Z-1976-2025

  • Audiometer

    Reason: Affected lots of product may experience technical distortions to a greater extent than expected.

    Z-0401-2024

  • Audiometer

    Reason: Affected lots of product may experience technical distortions to a greater extent than expected.

    Z-0402-2024

  • Audiometer

    Reason: Affected lots of product may experience technical distortions to a greater extent than expected.

    Z-0403-2024

  • Audiometer

    Reason: Affected lots of product may experience technical distortions to a greater extent than expected.

    Z-0404-2024

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

16 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Market reports on hearing

Search all
Medical Devices

Audiology Devices

Worldwide · 2024–2034

View report Public Health

Childhood Hearing Loss Public Health Report

Worldwide · 2024–2034

View report Medical Devices

Cochlear Implants

Worldwide · 2024–2034

View report Medical Devices

ENT Devices

Worldwide · 2024–2034

View report Medical Devices

Hearables

Worldwide · 2024–2034

View report Medical Devices

Hearing Aids (OTC)

Worldwide · 2024–2034

View report

From our blog

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Acuitas market sizes and forecasts are only in our full reports. How we use public data.