Consulting Wallah › Device Explorer › Other devices › Audiometric ear tip
Device Explorer · FDA GUDID · GMDN 62133

Audiometric ear tip

A luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ea

US‑registered devices160in commercial distribution
Companies6labelers on GUDID
Single‑use80%of device records
Sterile0%labelled sterile
Prescription24%Rx‑only share
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Share of device records

Etymotic Research, Inc.6440%
Interacoustics A/S5635%
Welch Allyn, Inc.2415%
3M Company106%
Intelligent Hearing Systems Corp.42%
Natus Medical Denmark Aps21%

Top labelers

CompanyDevicesShare
Etymotic Research, Inc.6440%
Interacoustics A/S5635%
Welch Allyn, Inc.2415%
3M Company106%
Intelligent Hearing Systems Corp.42%
Natus Medical Denmark Aps21%

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

Brand names on the register (sample)

OAE EartipsSanibel Supply A/SSanibel SupplyMaicoAmplivoxEtymoticN/AEtymotic ResearchSingle Use EartipSingle Use EartipsEarHugs for AccuScreenEarHug Pack - No ElectrodesCapella2 OAE Start-Up KitEarHugWelch Allyn, Inc.E-A-RLINK™

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

FDA product codes

CodeNameDevices
EWOAudiometer85
ETTCushion, Earphone (For Audiometric Testing)62
GWJStimulator, Auditory, Evoked Response28
PTPTympanometer, exempt24
ETTCUSHION, EARPHONE (FOR AUDIOMETRIC TESTING)10

GMDN & GCC registration

  • GMDN code 62133 · non‑implantable
  • Single‑use 80% · sterile 0% · Rx‑only 24% · OTC 34%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 59Lumen/Inner Diameter (Millimeter) · 13Height (Millimeter) · 13Length (Millimeter) · 8Outer Diameter (Inch) · 6Length (Inch) · 6

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

How many audiometric ear tip products are registered in the US?

160 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Audiometric ear tip", from 6 companies. The largest labeler is Etymotic Research, Inc. with 40% of records.

Which FDA product codes apply?

EWO (Audiometer), ETT (Cushion, Earphone (For Audiometric Testing)), GWJ (Stimulator, Auditory, Evoked Response), PTP (Tympanometer, exempt)

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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