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Device Explorer · FDA GUDID · GMDN 36717

Impedance audiometer

An electronic instrument used to evaluate the functional condition of the middle ear by changing the air pressure in the external auditory canal to measure and graph the mobility characteristics of the tympanic membrane. It identifies abnormalities in tympanic

US‑registered devices166in commercial distribution
Companies10labelers on GUDID
Single‑use9%of device records
Sterile0%labelled sterile
Prescription52%Rx‑only share
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Share of device records

Natus Medical Denmark Aps10664%
Welch Allyn, Inc.2616%
Inventis Srl1610%
Amplivox Limited42%
Wavely Diagnostics, Inc.42%
Diagnostic Group Llc32%
Interacoustics A/S21%
Path Medical Gmbh21%

Top labelers

CompanyDevicesShare
Natus Medical Denmark Aps10664%
Welch Allyn, Inc.2616%
Inventis Srl1610%
Amplivox Limited42%
Wavely Diagnostics, Inc.42%
Diagnostic Group Llc32%
Interacoustics A/S21%
Path Medical Gmbh21%
Maico Diagnostics Gmbh21%
M.R.S. Srl11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Madsen ZodiacMadsenGN Otometrics A/SOtometricsInteracousticsAmplivoxnanoTymp SetnanoTympMaico DEMaicoWavelyDx Ear Tip - Pack of 2WavelyDx Ear Tip - Pack of 6WavelyDx Middle Ear Fluid CMD iOS ApplicationWavelyDx Ear Tip - Pack of 3Grason-StadlerWelch Allyn, Inc.

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ETYTester, Auditory Impedance156
PTOTester, Auditory Impedance, Exempt22
ETTCushion, Earphone (For Audiometric Testing)13
EWOAUDIOMETER13
ETYTESTER, AUDITORY IMPEDANCE12
ETYTester, auditory impedance11

GMDN & GCC registration

  • GMDN code 36717 · non‑implantable
  • Single‑use 9% · sterile 0% · Rx‑only 52% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many impedance audiometer products are registered in the US?

166 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Impedance audiometer", from 10 companies. The largest labeler is Natus Medical Denmark Aps with 64% of records.

Which FDA product codes apply?

ETY (Tester, Auditory Impedance), PTO (Tester, Auditory Impedance, Exempt), ETT (Cushion, Earphone (For Audiometric Testing)), EWO (AUDIOMETER)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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