Sontro Self-Fitting OTC Hearing Aids

Basic Information

• Brand Name: Sontro Self-Fitting OTC Hearing Aids
• Primary DI: 00850016231130
• Version / Model: 990013-SWH
• Company Name: Soundwave Hearing, LLC
• Labeler DUNS: 050441605
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-01
• Public Version: 3
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: 735b8431-a008-493c-86c0-8729f167b903

Device Description

BEIGE/990013-SWH; right replacement for Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
QUH	Self-Fitting Air-Conduction Hearing Aid, Over The Counter	Ear, Nose, Throat	874.3325	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47169	Air-conduction hearing aid, receiver-in-canal	A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850016231130	GS1

Customer Contacts

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