# K963745: Model WMR Bte Hearing Instrument (Model WMR)

- Pathway: 510(k) (Traditional)
- Applicant: Hearing Innovations, Inc.
- Decided: Nov 26, 1996 after 70 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935095 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943788: Resound Personal Hearing System, Resound Corp. (1994) Summary page 2.
- K935095: 8260 Series 3M Programmable Hearing Instruments, 3M Company (1993) Summary page 2.
- K953543: 3M Model 8200P Multipro Bte, 3M Company (1995) Summary page 2.
- K951828: Full Dynamic Range Compression Behind the Ear Hearing Instrument, Siemens Hearing Instruments, Inc. (1995) Summary page 2.

## Indications for use
Intended to be used as a wearable sound amplifying device to compensate for mild to severe hearing loss.

Source page: https://510kreport.com/device/K963745
Methodology: https://510kreport.com/methodology