510(k) K211008

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

May 5, 2021

Date Received

April 5, 2021

Clearance Type

Special

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Self-Fitting Air-Conduction Hearing Aid, Prescription

Device Class

Class II

Regulation Number

874.3325

Review Panel

EN

Submission Type

A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. This is a prescription hearing aid.