FDA.reportPublic FDA data

Fonix

Primary DI
FONIX8000
Brand
Fonix
Company
FRYE ELECTRONICS, INC.
Model
8000
Device description
The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic, everyday tests of distortion, battery current drain, and frequency response to advanced tests of digital processing delay and phase. The FONIX 8000 is composed of a main electronics module with a front panelfor controlling the operation of the analyzer and a wide-format thermal printer. An external video monitor is used to view test results.
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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
FONIX8000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hearing aid tester, electricalAn assembly of electronic reference devices intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid, or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distortion analyser, a chart recorder, and a hearing aid test box. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

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
FONIXFP35FonixFP352016-08-22
B191FONIXCOLT0FonixColt2017-02-11
B191HEARLABACA0HearLabACA2017-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05711117244335Sanibel Supply A/SInteracoustics A/SETW2024-10-07
05711117228458Sanibel Supply A/SInteracoustics A/SETW2024-10-07
00810044583182MedRxMEDRX, INC.ETW2024-05-07
EADF03410600217207189audifonaudifon GmbH & Co. KGETW2023-03-31
05711117121742Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117094206Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117226478Sanibel Supply A/SInteracoustics A/SETW2022-12-29
05711117227550Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227574Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117227581Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228557Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228564Sanibel Supply A/SInteracoustics A/SETW2022-11-29
05711117228571Sanibel Supply A/SInteracoustics A/SETW2022-11-29
EADF034106002172068681audifonaudifon GmbH & Co. KGETW2022-10-21
05713315009037NatusNatus Medical Denmark ApSETW2021-04-12
05713315009044NatusNatus Medical Denmark ApSETW2021-04-12
05713315009051NatusNatus Medical Denmark ApSETW2021-04-12
05713315008689NatusNatus Medical Denmark ApSETW2021-01-04
B161RE3670Audioscan Probe TubeEtymonic Design IncorporatedETW2020-01-15
05711117198218InteracousticsInteracoustics A/SETW2019-11-26
B161VA3000Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
B161VA3003Verifit Skull SimulatorEtymonic Design IncorporatedETW2019-05-02
05713315005848GN Otometrics A/SNatus Medical Denmark ApSETW2019-04-24
05713315008184GN Otometrics A/SNatus Medical Denmark ApSETW2019-03-18
05713315005701GN Otometrics A/SNatus Medical Denmark ApSETW2018-11-06
05713315003301GN Otometrics A/SNatus Medical Denmark ApSETW2018-07-31
08054187380730DRUMINVENTIS SRLETW2017-08-24