Hearing Aid, Tactile
A tactile hearing aid is a device that converts sound signals into vibrotactile stimulation delivered to the skin surface, providing an alternative sensory channel for individuals with severe or profound hearing loss who cannot benefit from conventional acoustic hearing aids. This device is currently unclassified (Class U) by the FDA, meaning it has not been placed into a final regulatory classification category. The product code is LRA; no regulation number or medical specialty is on file for this entry. No special flags apply to this device.
Research product code LRA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- LRA
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883853 | ETA | Nov 17, 1988 | Substantially Equivalent | Sevrain-Tech, Inc. |
| K862471 | WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODER | Sep 12, 1986 | Substantially Equivalent | Institute of Logopedics |
| K851441 | TACTICON 1600 | Jun 27, 1985 | Substantially Equivalent | Medecon |
| K851655 | TEACHER TM | Jun 20, 1985 | Substantially Equivalent | Monargue Intl. |
| K843433 | KANIEVSKI SENSORY AID OR DEVICE | Nov 14, 1984 | Substantially Equivalent | Spectro Industries, Inc. |
| K831501 | TACTIL EAR | Aug 26, 1983 | Substantially Equivalent | Ear Three Systems |
| K830418 | TACTAID | Mar 10, 1983 | Substantially Equivalent | Audiological Engineering Corp. |
| K813057 | VIBRO-COM COMMUNICATOR #8827 | Dec 02, 1981 | Substantially Equivalent | Sonic Systems, Inc. |