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    Hearing Devices

    Air-conduction and bone-conduction hearing aids, OTC hearing aids, and cochlear implants — spanning Class I, II, and III pathways.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 9, 2026

    Definition

    The hearing-devices segment covers prescription air-conduction hearing aids, the FDA-created OTC hearing aid category (effective October 2022 under 21 CFR 800.30), bone-anchored hearing systems, and cochlear implants. The 2022 OTC rule fundamentally restructured the consumer end of the market by allowing direct-to-consumer sale of mild-to-moderate hearing-loss devices to adults without an audiologist visit.
    What the regulation says
    21 CFR 800.30 (OTC hearing aids), 21 CFR 874.3300 (prescription hearing aids), and 21 CFR 874.3450 (bone-conduction). Cochlear implants are Class III PMA devices under product code MCM.

    What this means in practice

    OTC hearing aids brought new entrants (Apple AirPods Pro hearing-aid feature, Sony, Bose) and price compression on traditional prescription products. Insurance coverage remains uneven; Medicare does not cover most hearing aids.
    Common pitfalls
    • •Marketing personal sound amplification products (PSAPs) with hearing-loss claims — that triggers FDA hearing-aid regulation.
    • •Forgetting that pediatric hearing aids remain prescription-only under the OTC rule.

    Primary references

    3 sources
    Link health: 1 verified 1 bot-blocked 1 needs review· last checked 2026-05-09
    FDA·1eCFR·1MedTech Europe·1
    1. 1
      FDA — OTC Hearing Aids Final Rule
      Bot-blocked
      FDAfda.gov
    2. 2
      21 CFR 800.30 OTC Hearing Aids
      Needs review
      eCFRecfr.gov
    3. 3
      MedTech Europe - Facts & Figures
      Verified
      MedTech Europemedtecheurope.org

    Inline markers like [1] jump to the matching reference above.