FDA.reportPublic FDA data

contact

Primary DI
09120041059711
Brand
contact
Company
BHM-Tech Produktionsgesellschaft m.b.H.
Model
contact forte Alpha
Catalog number
77735910
Device description
bone conduction hearing aid, ALPHA, RT/red
Published
2026-02-17
Public version status
Update
Distribution status
Not 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
09120041059711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120041059711091200410597119120041059711

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

Sterilization Methods#

Method table
Method

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
09120041056895Hearbowcontact forte/SW777360972026-04-17
09120041056673contact forte AlphaBP/USA777359452026-04-17
09120041056697contact forte AlphaBB/USA777359412026-04-17
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
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

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
05712149027453PontoOticon Medical ABLXB2023-08-21
05712149027460PontoOticon Medical ABLXB2023-08-21
05712149027477PontoOticon Medical ABLXB2023-08-21
05712149027484PontoOticon Medical ABLXB2023-08-21
05712149027491PontoOticon Medical ABLXB2023-08-21
05712149027507PontoOticon Medical ABLXB2023-08-21
05712149027514PontoOticon Medical ABLXB2023-08-21
05712149027521PontoOticon Medical ABLXB2023-08-21
05712149026562PontoOticon Medical ABLXB2022-09-17
05712149026579PontoOticon Medical ABLXB2022-09-17
05712149026586PontoOticon Medical ABLXB2022-09-17
05712149026593PontoOticon Medical ABLXB2022-09-17
05712149026609PontoOticon Medical ABLXB2022-09-17
05712149026616PontoOticon Medical ABLXB2022-09-17
05712149026623PontoOticon Medical ABLXB2022-09-17
05712149026630PontoOticon Medical ABLXB2022-09-17
05712149026722PontoOticon Medical ABLXB2022-09-17
05712149026739PontoOticon Medical ABLXB2022-09-17