Audiometer
Ear, Nose, Throat · 21 CFR 874.1050
Recent MDR events
63 adverse event reports on file
- Headband HB-7 for TDH39Jul 27, 2026Injury9612197-2026-00016
- HEADBAND HB-7 FOR TDH39Jun 8, 2026Injury9612197-2026-00013
- HEADBAND HB-7 FOR TDH39Jun 8, 2026Injury9612197-2026-00014
- HEADBAND HB-7 FOR TDH39May 26, 2026Injury9612197-2026-00012
- HEADBAND HB-7 FOR TDH39May 26, 2026Injury9612197-2026-00011
- HEADBAND HB-7 FOR TDH39May 19, 2026Injury9612197-2026-00010
- HEADBAND HB-7 FOR TDH39May 19, 2026Injury9612197-2026-00009
- HEADBAND HB-7 FOR TDH39Feb 19, 2026InjuryNatus Medical Incorporated9612197-2026-00005
- MADSEN ASTERA 2Feb 3, 2026InjuryNatus Medical Incorporated9612197-2026-00003
- HEADBAND HB-7 FOR TDH39Dec 16, 2025Injury9612197-2025-00016
Event type breakdown
Recalls
5 recall events for this product code
- PATHOpen, ClassifiedNov 25, 2023
SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0401-2024 · View FDA record ↗ - PATHOpen, ClassifiedNov 25, 2023
SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0402-2024 · View FDA record ↗ - PATHOpen, ClassifiedNov 25, 2023
AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0403-2024 · View FDA record ↗ - PATHOpen, ClassifiedNov 25, 2023
SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0404-2024 · View FDA record ↗ - Cardinal Health, IncTerminatedNov 12, 2008
GSI Audera (version 2.6 software) Viasys Healthcare, Inc.
GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction: GSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear. When using 2.6 software in split-screen mod
Z-0195-2009 · View FDA record ↗
Registered firms
130 firms currently registered for this product code
Zoomax Technology Co., Limited
Hangzhou Zhejiang, CN
Diagnostic Group Llc
EDEN PRAIRIE, MN, US
Interacoustics A/s
Middelfart Syddanmark, DK
Oscilla A/s
8200 Midtjylland, DK
Intelligent Hearing Systems Corp.
MIAMI, FL, US
Resonance Of America, Inc
New York, NY, US
Dgs Diagnostics Sp. Z O.o
Kolbaskowo Zachodniopomorskie, PL
Welch Allyn, Inc.
Skaneateles Falls, NY, US
Teleemg, Llc
E Falmouth, MA, US
Etymotic Research, Inc.
Schaumburg, IL, US
Path
Germering Bavaria, DE
Worldwide Supplies Limited
Hong Kong, HK
Natus Medical Denmark Aps
TAASTRUP Hovedstaden, DK
Otodynamics, Ltd.
HATFIELD, HERTS Hertfordshire, GB
Hearx Usa
Dekalb, IL, US
510(k) clearances
235 clearances for this product code
- OtodynamicsJun 21, 2024
K234095 · OtoNova/OtoNova Pro
- Otodynamics, Ltd.Mar 15, 2024
K240430 · Otoport Pro
- Hearx SA (Pty) , Ltd.Oct 27, 2023
K231545 · hearOAE
- Path Medical GmbHJun 22, 2022
K213345 · Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
- Interacoustics A/SJul 15, 2019
K191372 · Lyra
- Grason-Stadler, Inc.May 11, 2018
K180287 · GSI Corti
- Interacoustics A/SFeb 14, 2018
K173567 · Sera
- Grason-Stadler, Inc.Oct 20, 2017
K172403 · GSI Novus