HEAR.COM LLC (TELE-DX)

FDA Device Registration & Listing · Coral Gables, FL, US · Registration 3013333417

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013333417
FEI Number
3013333417
Entity Name
HEAR.COM LLC (TELE-DX)
City/State/Country
Coral Gables, FL, US
Establishment Address
396 Alhambra Cir Ste 1200, Coral Gables, FL 33134, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
hear.com (Tele-Dx) (Owner Number: 10095758)
Owner / Operator Contact Address
396 Alhambra Cir, S1200, Miami, FL 33134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Tele-Dx

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2026-04-24

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

hear.com (Tele-Dx)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K780270 Maico Hearing Instruments, Inc. COMPUTER AUDIOMETER - MA26 1978-02-27
K923074 Life-Tech Intl., Inc. DANPLEX SCREENING AUDIOMETER 1992-09-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013333417. Last updated year: 2026. Please use registration number 3013333417 when referencing this establishment in official correspondence.
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