otoTune app

Basic Information

• Brand Name: otoTune app
• Primary DI: 00850016231383
• Version / Model: 990019-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: 5
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: 832b6641-36e6-4061-8eaa-d5d28cd7f99e

Device Description

APP, Bluetooth, otoTune iOS for 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: No
• 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
60211	Audiometric/hearing device software	A software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850016231383	GS1

Customer Contacts

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