510(k) K251208

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 26, 2025

Date Received

April 18, 2025

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Air-Conduction Hearing Aid Software

Device Class

Class II

Regulation Number

874.3335

Review Panel

EN

Submission Type

Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in this classification are also subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. This classification does not include software that is used with hardware as part of a hearing-aid device system classified in other regulations, e.g., § 874.3300, § 874.3305, or § 874.3325.