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Hhm

FDA UDI

Class II (US FDA UDI)

by Oticon A/S

Identity

Trade Name
HHM FDA UDI
Generic Name
Air-conduction hearing aid, receiver-in-the-ear FDA UDI
Device Name
G300 SC, MINIRITE 312 2.4G C093 HHM FDA UDI
Model / Reference
201783 FDA UDI
Description
G300 SC, MINIRITE 312 2.4G C093 HHM FDA UDI

Identifiers

Primary DI / UDI-DI
05707131355157 FDA UDI
FDA Product Code
OSM FDA UDI
GMDN Term
Air-conduction hearing aid, receiver-in-the-ear FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3305 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Air-conduction hearing aid, receiver-in-the-ear

The HHM (Hearing House Model) is a battery-powered acoustic device designed to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It's an implantable, single-use model used for mild to profound hearing loss, and its electronic components are programmable to enable computerized adjustments for individual patients.

Similar devices

Also classified as Air-conduction hearing aid, receiver-in-the-ear.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oticon A/S

Sources (1)

  • FDA UDI 061b6ab2-2f12-48ce-8115-17dbe410072f 34 fields · synced Jul 30, 2026