FDA.reportPublic FDA data

contact forte Alpha

Primary DI
09120041056697
Brand
contact forte Alpha
Company
BHM-Tech Produktionsgesellschaft m.b.H.
Model
BB/USA
Catalog number
77735941
Device description
bone conduction hearing aid, ALPHA, BB/babyblue
Published
2026-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K243041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243041000contact forte AlphaBhm-Tech Produktionsgesellschaft Mbh2025-04-25LXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120041052897PackageGS11In Commercial Distribution
09120041056697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120041052897091200410528979120041052897
09120041056697091200410566979120041056697

GMDN Terms#

Term, Definition table
TermDefinition
Bone-conduction hearing aid, head-wornAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+43335920078regulatory.request@bhm-tech.com

Regulatory Flags#

DUNS number
300632705
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120041056673contact forte AlphaBP/USA777359452026-04-17
09120041056703contact forte AlphaBL/USA777359432026-04-17
09120041056710contact forte AlphaRT/USA777359472026-04-17
09120041056727contact forte AlphaSW/USA777359492026-04-17
09120041056734contact forteBB/USA777361252026-04-17
09120041056741contact forteBL/USA777361262026-04-17
09120041056758contact forteBP/USA777361272026-04-17
09120041056765contact forteRT/USA777361282026-04-17
09120041056772contact forteSW/USA777361292026-04-17
09120041056895Hearbowcontact forte/SW777360972026-04-17
09120041052149contactcontact mini777352012026-02-17
09120041052156contactcontact mini777352022026-02-17
09120041052163contactcontact mini777352032026-02-17
09120041052309contactcontact mini777354292026-02-17
09120041052316contactcontact mini777354282026-02-17
09120041052323contactcontact mini777354272026-02-17
09120041059575contactcontact forte777359162026-02-17
09120041059582contactcontact forte777358972026-02-17
09120041059599contactcontact forte777358982026-02-17
09120041059605contactcontact forte777358992026-02-17

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
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
09120041059667contactBHM-Tech Produktionsgesellschaft m.b.H.LXB2026-02-17