FDA.reportPublic FDA data

ADHEAR User Kit, Terra Brown

Primary DI
09008737381981
Brand
ADHEAR User Kit, Terra Brown
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
38198
Device description
Audio Processor Kit
Published
2019-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXBHearing Aid, Bone Conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXBHearing Aid, Bone ConductionEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172460000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172460000ADHEAR SystemMed-El Elektromedizinische Geraete GmbH2018-04-27LXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737381981PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737381981090087373819819008737381981

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn bone-conduction hearing aidAn electrically-powered acoustic device intended to compensate for impaired hearing by transmitting vibrations, from transduced sound waves, through the skull to the inner ear. It typically consists of a microphone, amplifier, and vibrator mounted or magnetically connected to a headband, spectacles or an implantable magnet; 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)633-3524implants.us@medel.com

Regulatory Flags#

DUNS number
300764032
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09008737583262SoftGrip Forceps583262021-04-09
09008737415808Verifit Adapter415802025-11-17
09008737002848Surgical Claw angled002842014-09-22
09008737455712AudioLink XT Kit455712025-02-26
09008737458904AudioLink XT Core Kit458902025-02-26
09008737415433Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet41543415472024-10-15
09008737415440Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet41544415482024-10-15
09008737416218Insertion Electrode FLEX34416212024-10-15
09008737304928SONNET FM Battery Pack Cover anthracite304922015-02-28
09008737308339SONNET FM Battery Pack Cover ebony308332015-02-28
09008737308346SONNET FM Battery Pack Cover black308342015-02-28
09008737308353SONNET FM Battery Pack Cover white308352015-02-28
09008737308360SONNET FM Battery Pack Cover beige308362015-02-28
09008737308377SONNET FM Battery Pack Cover nordic grey308372015-02-28
09008737049997OPUS 2 FM Extension Kit anthracite049992022-09-15
09008737050009OPUS 2 Children's Extension Kit anthracite050002022-09-15
09008737050030OPUS 2 FM Extension Kit beige050032022-09-15
09008737050047OPUS 2 Children's Extension Kit beige050042022-09-15
09008737050078OPUS 2 FM Extension Kit red050072022-09-15
09008737050085OPUS 2 Children's Extension Kit red050082022-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05712149027743Ponto InstantOticon Medical ABLXB2026-05-21
09120041056673contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056697contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056703contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056710contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056727contact forte AlphaBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056734contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056741contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056758contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056765contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056772contact forteBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041056895HearbowBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-04-17
09120041050145contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050176contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050190contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041050220contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051852contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041051906contact miniBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052149contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052156contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052163contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052309contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052316contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041052323contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059575contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059582contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059599contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059605contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059612contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17
09120041059650contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17