File 003 · AgeTech

Record 160 · Health · 2022

22.160.H

Sony CRE-C10

Sony

Sony CRE-C10 (2022) by Sony

Sony's first over-the-counter hearing aids — earbuds that are medical devices.

An OTC aid from a consumer-electronics giant.

CRE-C10 arrived with the FDA OTC rule: self-fit, rechargeable, sold like Walkmans used to be. It put a consumer-electronics brand in the hearing aisle.

Consumer-electronics OTC at the rule's opening.

Filed notes

  • Self-fit OTC
  • Completely-in-canal OTC
  • Electronics-retail channel

SIC

3842

Orthopedic, Prosthetic, and Surgical Appliances and Supplies

NAICS

334510

Electromedical and Electrotherapeutic Apparatus Manufacturing

Official

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