510(k) DEN180026

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

October 5, 2018

Date Received

May 11, 2018

Clearance Type

Direct

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.