FDA.reportPublic FDA data

Fonix

Primary DI
FONIXFP35
Brand
Fonix
Company
FRYE ELECTRONICS, INC.
Model
FP35
Device description
The FONIX FP35 provides quick, accurate information about how well a hearing aid works. It uses a graphical display or numerical table to show how much amplification the aid provides, which frequencies it amplifies, and how much distortion is creates. The FP35 analyzer is meant to be used primarily by hearing health professionals who fit hearing aids on hearing-impaired adults and children throughout the world.
Published
2016-08-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETWCalibrator, Hearing Aid / Earphone And Analysis Systems
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETWCalibrator, Hearing Aid / Earphone And Analysis SystemsEar, Nose, Throat2
EWOAudiometerEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
FONIXFP35PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tone audiometer, manualAn electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. Changes in tone intensity, frequency, and the recording of patient responses are all performed manually.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5036202722sales@frye.com

Regulatory Flags#

DUNS number
058131475
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
FONIX8000Fonix80002016-08-22
B191FONIXCOLT0FonixColt2017-02-11
B191HEARLABACA0HearLabACA2017-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810046707562Grason-StadlerDiagnostic Group LLCEWO2026-06-04
05745000311064OscillaOscilla A/SEWO2026-05-29
05745000311095OscillaOscilla A/SEWO2026-05-29
05745000311156OscillaOscilla A/SEWO2026-05-29
05745000311163OscillaOscilla A/SEWO2026-05-29
05745000311187OscillaOscilla A/SEWO2026-05-29
05745000311200OscillaOscilla A/SEWO2026-05-29
00810046707180Grason-StadlerDiagnostic Group LLCEWO2026-04-06
057117810041053000 Real EarAuditdata A/SEWO2026-01-23
057117810041363000 Real EarAuditdata A/SEWO2026-01-23
057117810041433000 Real EarAuditdata A/SEWO2026-01-23
057117810041503000 Real EarAuditdata A/SEWO2026-01-23
057117810041673000 Real EarAuditdata A/SEWO2026-01-23
057117810041743000 Real EarAuditdata A/SEWO2026-01-23
B43056000011110GoCheckGobiquity, Inc.EWO2026-01-09
B43056000011100GoCheckGobiquity, Inc.EWO2025-12-02
05060753520090Tympa Otoscope SystemTYMPA HEALTH TECHNOLOGIES LIMITEDEWO2025-11-19
B43071000030GoCheck MultiScreenerGobiquity, Inc.EWO2025-11-19
05711781004204Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004211Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004228Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004235Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004242Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004259Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004266Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004280Measure by OtometricsAuditdata A/SEWO2025-11-14
05711781004297Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711781004372Measure by Otometrics - HITAuditdata A/SETW2025-11-14
05711117230833Sanibel Supply A/SInteracoustics A/SEWO2025-08-07
05711117230840Sanibel Supply A/SInteracoustics A/SEWO2025-08-07