# K971296: Tondi, Models U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05

- Pathway: 510(k) (Traditional)
- Applicant: National Hearing Aid Dist., Inc.
- Decided: Jun 20, 1997 after 74 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies). The indications for use of this air conduction hearing aid in this submission is to amplify sound for individuals with impaired hearing. The device(s) is/are indicated for individuals with losses in the following category(ies).

Source page: https://510kreport.com/device/K971296
Methodology: https://510kreport.com/methodology