# K080955: Zen Program (Mind 440 Hearing Aid)

- Pathway: 510(k) (Traditional)
- Applicant: Widex Hearing Aid Co., Inc.
- Decided: Jun 27, 2008 after 85 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: 3 generations back to K974501 (1998). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043274: Neuromonics Tinnitus Treatment, Neuromonics Pty, Ltd. (2005) Summary page 1.
- K011366: Custom Tci-Combi (Tinnitus Control Instrument Combination), Siemens Hearing Instruments, Inc. (2001). Our reading of the summary gave K001366, FDA’s number for Prostec 125I Branchytherapy Snapseed (Prostec, LLC). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Siemens Custom TCI-Combi”. Summary page 1.
- K974501: Digital Tinnitus Masking System, Petroff Audio Technologies (1998) Summary page 1.

## Most influential descendants
- K110973: IE-Zen (in Clear Series Hearing Aid) (2011), 4 descendants of its own
- K123450: Phonak Tinnitus Balance (2013), 3 descendants of its own
- 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 Zen program is intended to provide a relaxing sound background for adults (21 years and older) who desire to listen to such a background in quiet. It may be used as a sound therapy tool in a tinnitus treatment program that is prescribed by a licensed hearing healthcare professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management.

Source page: https://510kreport.com/device/K080955
Methodology: https://510kreport.com/methodology