Medical Device Manufacturer · DK , Ballerup

GN Hearing A/S - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2018

Recent clearances: Jabra Enhance Plus, Tinnitus Sound Generator Module, Tinnitus Sound Generator Module

5

Total

5

Cleared

0

Denied

FDA 510(k) Regulatory Record - GN Hearing A/S Ear, Nose, Throat ✕

5 devices

1-5 of 5

Cleared Jun 25, 2026

Jabra Enhance Select Self-fit (Jabra Enhance Select 550)

Ear, Nose, Throat · 188d

Cleared Jan 19, 2022

Jabra Enhance Plus

Ear, Nose, Throat · 90d

Cleared Feb 20, 2020

Tinnitus Sound Generator Module

Ear, Nose, Throat · 83d

Cleared Nov 30, 2018

Tinnitus Sound Generator Module

Ear, Nose, Throat · 277d

Cleared Jul 13, 2018

Tinnitus Sound Generator Module

Ear, Nose, Throat · 28d