Consulting Wallah › Device Explorer › Other devices › Tone audiometer
Device Explorer · FDA GUDID · GMDN 37503

Tone audiometer

An electroacoustic device intended for use in a clinical setting to generate tones in the audible range to measure the hearing threshold of a patient by establishing the level at which the patient first becomes aware of the sounds. The device controls tone int

US‑registered devices132in commercial distribution
Companies24labelers on GUDID
Single‑use2%of device records
Sterile0%labelled sterile
Prescription42%Rx‑only share
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Share of device records

Inventis Srl2418%
Maico Diagnostics Gmbh2015%
Natus Medical Denmark Aps129%
Path Medical Gmbh129%
Diagnostic Group Llc118%
Emoyodotnetza (Pty) Ltd65%
Oscilla A/S65%
Medrx, Inc.65%

Top labelers

CompanyDevicesShare
Inventis Srl2418%
Maico Diagnostics Gmbh2015%
Natus Medical Denmark Aps129%
Path Medical Gmbh129%
Diagnostic Group Llc118%
Emoyodotnetza (Pty) Ltd65%
Oscilla A/S65%
Medrx, Inc.65%
Amplivox Limited54%
Interacoustics A/S43%
Etymotic Research, Inc.43%
Intelligent Hearing Systems Corp.32%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AudyxKUDUwaveOscillaMadsen A450Bone Conductor (BC-2)NatusOtometricsInteracousticsOrfit IndustriesAmplivoxnanoAudio DD65v2 Set with Patient Response ButtonanoAudio DD65v2 Set with Patient Response ButtonanoAudio DD65v2 SetnanoAudio DD45 Set with Patient Response Button nanoAudio DD45 Set with Patient Response ButtonnanoAudio DD45 Set

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

FDA product codes

CodeNameDevices
EWOAudiometer159
ETYTester, Auditory Impedance2
IYEAccelerator, linear, medical2
GWJStimulator, Auditory, Evoked Response2
ETTCushion, Earphone (For Audiometric Testing)2
PTOTester, Auditory Impedance, Exempt2

GMDN & GCC registration

  • GMDN code 37503 · non‑implantable
  • Single‑use 2% · sterile 0% · Rx‑only 42% · OTC 8%
  • 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.

How many tone audiometer products are registered in the US?

132 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tone audiometer", from 24 companies. The largest labeler is Inventis Srl with 18% of records.

Which FDA product codes apply?

EWO (Audiometer), ETY (Tester, Auditory Impedance), IYE (Accelerator, linear, medical), GWJ (Stimulator, Auditory, Evoked Response)

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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