EWO · Class II · 21 CFR 874.1050

FDA Product Code EWO: Audiometer

Leading manufacturers include Interacoustics A/S, Grason-Stadler, Inc. and Path Medical GmbH.

235

Total

235

Cleared

103d

Avg days

1976

Since

Declining activity - 0 submissions in the last 2 years vs 3 in the prior period

FDA 510(k) Cleared Audiometer Devices (Product Code EWO)

235 devices

1–24 of 235

1 2 3 4

Ear, Nose, Throat · 178d

Ear, Nose, Throat · 30d

Cleared Oct 27, 2023

hearOAE

K231545

Hearx SA (Pty) , Ltd.

Ear, Nose, Throat · 150d

Cleared Jun 22, 2022

Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE

K213345

Path Medical GmbH

Ear, Nose, Throat · 257d

Ear, Nose, Throat · 54d

Ear, Nose, Throat · 99d

Ear, Nose, Throat · 86d

1 2 3 4

About Product Code EWO - Regulatory Context

510(k) Submission Activity

235 total 510(k) submissions under product code EWO since 1976, with 235 receiving FDA clearance (average review time: 103 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.

FDA Product Code EWO: Audiometer

FDA 510(k) Cleared Audiometer Devices (Product Code EWO)

About Product Code EWO - Regulatory Context

510(k) Submission Activity

Related FDA 510(k) Regulatory Insights