ADHEAR User Kit, Terra Brown

Basic Information

• Brand Name: ADHEAR User Kit, Terra Brown
• Primary DI: 09008737382032
• Version / Model: 38203
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-08
• Public Version: 4
• Public Version Date: 2024-02-22
• Public Version Status: Update
• Public Device Record Key: 342ab12b-5c4e-4fe0-88e2-652a2c5e83b1
• Distribution End Date: 2024-01-31

Device Description

Audio Processor Kit (without headband)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
LXB	Hearing Aid, Bone Conduction	Ear, Nose, Throat	874.3302	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65091	Bone-conduction hearing aid, head-worn	An electrically-powered, external, acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically incorporates a microphone, amplifier, and vibrator mounted or magnetically connected to a head-worn device (e.g., headband or spectacles); it may include positioning and protection devices. The microphone receives sound waves and converts them into electrical signals sent to the vibrator which transmits vibrations, typically through the mastoid bone, to the inner ears for hearing. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737382032	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172460	000

Storage Conditions

• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -13 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius