# K123450: Phonak Tinnitus Balance

- Pathway: 510(k) (Abbreviated)
- Applicant: Phonak, LLC
- Decided: Feb 11, 2013 after 94 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K974501 (1998). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110932: Tinnitus Sound Generator Module, Gn Resound A/S (2011) Summary page 1.
- K110973: IE-Zen (in Clear Series Hearing Aid), Widex USA (2011) Summary page 1.
- K003558: Tci Combi (Tinnitus Control Instrument Combination), Siemens Hearing Instruments, Inc. (2001) Summary page 1.

## Most influential descendants
- K133308: Tinnitus Soundsupport (2014), 2 descendants of its own
- K151719: REVE134 (2015), 1 descendant of its own
- K221168: Tinnitogram Signal Generator (2023), 0 descendants of its own

## Indications for use
The target group for the Phonak Tinnitus Balance software feature are adults 18 years of age or older with tinnitus who also desire amplification. The Tinnitus Balance software feature and accompanying hearing aid amplification is fit by a licensed hearing healthcare professional (audiologist, hearing aid specialist, otolaryngologist) familiar with the diagnosis and management of tinnitus. Phonak hearing aids provide amplification to address sensorineural, conductive, or mixed hearing losses. Depending on the specific model, Phonak hearing aids cover fitting ranges from mild to profound hearing losses. Before being fit with Tinnitus Balance, individuals presenting with tinnitus should be assessed by a licensed ear physician to confirm the source of their tinnitus is not due to any of the following medical conditions: *Visible congenital or traumatic deformity of the ear *Any active drainage from the ear within the previous 90 days *Sudden hearing loss within the previous 90 days *Acute or chronic dizziness *Unilateral hearing loss of sudden or recent onset within the previous 90 days *Pain or discomfort in the ear

Source page: https://510kreport.com/device/K123450
Methodology: https://510kreport.com/methodology