Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1052698

FEI Number

1000113652

Entity Name

AUDINA HEARING INSTRUMENT, INC

City/State/Country

LONGWOOD, FL, US

Establishment Address

165 E Wildmere Ave, LONGWOOD, FL 32750, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

AUDINA HEARING INSTRUMENT (Owner Number: 9000174)

Owner / Operator Contact Address

165 E. WILDMERE AVE., --, Longwood, FL 32750, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AUDINA PREWIRED FACEPLATE AUDINA INSTINCT AUDINA OPTI-TRIM AUDINA Sparo Audina AGC-o AUDINA INTUITION 2 AUDINA Sparo 2ER AUDINA Cue AUDINA INTUITION AD AUDINA SIMPLEX FC ez HEAR AUDINA ezHEAR Intuition 2ER Audina IRIC 2 AUDINA FLX Audina IRIC 6 Audina Simplex 2P+ AUDINA SIMPLEX AUDINA Arc Audina Arro 12 AUDINA INTUITION 2 FC AUDINA nVe 4 AUDINA SIMPLEX EZHEAR Audina Arro 6 Audina FLX 12 AUDINA Intuition 2FC+ AUDINA Accurio Audina Sparo 2+ AUDINA 13 D2 Audina BTE D6HP Audina FLX 6 AUDINA INTUITION 4 AD Audina OCTANE 12 AUDINA nVe AD AUDINA SIMPLEX FC AUDINA EZHEAR CD4 Audina IRIC 12 Audina InstaFIT Audina Intuition 6AD Audina OCTANE T AUDINA Intuition 12 AUDINA PARAGON-4 AUDINA Sparo AD AUDINA INTELLIO AUDINA PARAGON 2 Audina Arro 6AD Audina FLX 4 AUDINA INTUITION 4 Audina FIDO PRO Audina IRIC 4 AUDINA SIMPLEX 2P AUDINA Intuition 12 AD Audina Push Pull Audina Super 60 AUDINA FOUNDATION Audina Intuition 6 Audina OCTANE 6 AUDINA ez HEAR Intuition 4 AUDINA INTUITION D AUDINA 478 Audina BTE D6P Audina FLX E AUDINA INTUITION 4+ Audina OCTANE 4 Audina 675DP+ AUDINA Sparo 2 Audina Arro 2 AUDINA Intuition 2+ AUDINA 675 D2 Audina BTED275 Audina Analog + AUDINA Intuition 2 ER Audina 478P+ Audina BTE6AD AUDINA Sparo 12 Audina 675 D2 HP Audina Class A AUDINA Intuition 8 AUDINA 478 P AUDINA NUEVE AUDINA SIMPLEX 2 AUDINA 675 DP Audina Class D AUDINA INTUITION 8 AD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRB	Face Plate Hearing Aid	Ear, Nose, Throat	Class 1	874.3300	1992-07-15
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	1992-07-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AUDINA HEARING INSTRUMENT

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
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1052698. Last updated year: 2026. Please use registration number 1052698 when referencing this establishment in official correspondence.