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Device Explorer · FDA GUDID · GMDN 35368

Auditory stimulator

A mains electricity (AC-powered) device that applies sound stimuli (e.g., pure tones, speech) to a patient's acoustic system. It is typically used as a component of several types of devices such as audiometers, auditory evoked-potential recording systems, and

US‑registered devices159in commercial distribution
Companies6labelers on GUDID
Single‑use21%of device records
Sterile0%labelled sterile
Prescription20%Rx‑only share
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Share of device records

Natus Medical Denmark Aps12478%
Etymotic Research, Inc.2918%
Sound Health Systems Inc21%
Medtronic Xomed, Inc.21%
Ge Healthcare Finland Oy11%
Cochlear Limited11%

Top labelers

CompanyDevicesShare
Natus Medical Denmark Aps12478%
Etymotic Research, Inc.2918%
Sound Health Systems Inc21%
Medtronic Xomed, Inc.21%
Ge Healthcare Finland Oy11%
Cochlear Limited11%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AccuScreen EarcouplersAccuScreenAccuscreen1077 AccuScreenVemp MonitorICSMadsen AccuscreenMadsen AccsucreenGN Otometrics A/SSonu (Gray Headband)Sonu (Black Headband)N/AER-2ER-1Etymotic ResearchNA

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

FDA product codes

CodeNameDevices
GWJStimulator, Auditory, Evoked Response158
EWOAudiometer39
LNHSystem, Nuclear Magnetic Resonance Imaging3
GWNNystagmograph3
QZCExternal Mechanical Stimulator For The Relief Of Congestion2
GXZELECTRODE, NEEDLE2

GMDN & GCC registration

  • GMDN code 35368 · non‑implantable
  • Single‑use 21% · sterile 0% · Rx‑only 20% · OTC 19%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Feet) · 4

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How many auditory stimulator products are registered in the US?

159 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Auditory stimulator", from 6 companies. The largest labeler is Natus Medical Denmark Aps with 78% of records.

Which FDA product codes apply?

GWJ (Stimulator, Auditory, Evoked Response), EWO (Audiometer), LNH (System, Nuclear Magnetic Resonance Imaging), GWN (Nystagmograph)

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.

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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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