Fonix

Basic Information

• Brand Name: Fonix
• Primary DI: FONIXFP35
• Version / Model: FP35
• Company Name: FRYE ELECTRONICS, INC.
• Labeler DUNS: 058131475
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-22
• Public Version: 4
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: afa78752-23c5-4e2c-8c69-3866db69b161

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EWO	Audiometer	Ear, Nose, Throat	874.1050	2
ETW	Calibrator, Hearing Aid / Earphone And Analysis Systems	Ear, Nose, Throat	874.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41184	Tone audiometer, manual	An 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.	No	Obsolete
41217	Hearing aid tester, electrical	An assembly of electronic reference devices intended to be used by a healthcare provider in a clinical setting to verify the performance of and/or calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid or group auditory trainer. The device typically consists of an acoustic complex of known cavity volume, a sound level meter, microphone, oscillators, frequency counters, microphone amplifiers, distortion analyser, chart recorder, and a hearing aid test box; some types may include a probe microphone used for real-ear measurement (REM). It does not measure hearing acuity [i.e., it is not an audiometer].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	FONIXFP35	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]