FDA.reportPublic FDA data

Hearbow

Primary DI
09120041056895
Brand
Hearbow
Company
BHM-Tech Produktionsgesellschaft m.b.H.
Model
contact forte/SW
Catalog number
77736097
Device description
Hearbow for contact forte, SW/black Accessory for use with contact forte bone conduction hearing aid
Published
2026-04-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
09120041056895PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120041056895091200410568959120041056895

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn hearing aid holder, reusableA device intended to be fixed/worn on a patient’s head to hold an air- or bone-conduction hearing aid; it may in addition be designed to hold a hearing aid dummy/counterbalance. It may be adhered to the skin, magnetically held in place on the side of the head by an implantable magnet (not included), attached to existing clothing (e.g., hat,) or spectacles, or worn like a headband. Dedicated devices (e.g., scale) used in the fitting process may be packaged with the holder. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
300632705
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
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
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