# K971852: Air Conduction Haearing Aids

- Pathway: 510(k) (Traditional)
- Applicant: Beltone Electronics Corp.
- Decided: Aug 15, 1997 after 87 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 K940102 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951587: Beltone Petite Plus Beltone Petite Plus Clearvioce K, Beltone Electronics Corp. (1995) Summary page 1.
- K940102: Beltone Opera/Opera MHP/Opera Max, Beltone Electronics Corp. (1994) Summary page 1.
- K940098: Beltone Invisa, Beltone Electronics Corp. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K954213: Ath Full Profile Acetabular Cup System, Kinamed, Inc. (1995). Our OCR of the scanned summary read K954213, FDA’s number for Ath Full Profile Acetabular Cup System (Kinamed, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Beltone Optima 2000”. Kept off the family tree.

## Indications for use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies):

Source page: https://510kreport.com/device/K971852
Methodology: https://510kreport.com/methodology