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Device Explorer · FDA GUDID · GMDN 31940

Earphone cushion

A device that is part of an earphone, sometimes detachable, which rests against the ear or head. In the case of audiometric ear phones the cushion is part of the specification for calibration purposes.

US‑registered devices157in commercial distribution
Companies4labelers on GUDID
Single‑use96%of device records
Sterile4%labelled sterile
Prescription4%Rx‑only share
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Share of device records

Grason & Associates Llc14492%
Welch Allyn, Inc.64%
Interacoustics A/S53%
Dynarex Corporation21%

Top labelers

CompanyDevicesShare
Grason & Associates Llc14492%
Welch Allyn, Inc.64%
Interacoustics A/S53%
Dynarex Corporation21%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sanibel Supply A/SSanibel SupplyGrason & Associates, LLCNasal Oxygen Cannula Advantage Ear Foam CoversResp-O2 Nasal Oxygen Cannula Deluxe Ear Foam CovWelch 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
ETTCushion, Earphone (For Audiometric Testing)149
ETYTester, auditory impedance6
BYXTubing, Pressure And Accessories2
CATCannula, Nasal, Oxygen2

GMDN & GCC registration

  • GMDN code 31940 · non‑implantable
  • Single‑use 96% · sterile 4% · Rx‑only 4% · OTC 0%
  • 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 earphone cushion products are registered in the US?

157 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Earphone cushion", from 4 companies. The largest labeler is Grason & Associates Llc with 92% of records.

Which FDA product codes apply?

ETT (Cushion, Earphone (For Audiometric Testing)), ETY (Tester, auditory impedance), BYX (Tubing, Pressure And Accessories), CAT (Cannula, Nasal, Oxygen)

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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