# K093715: Evok 900 Series Hearing Aid/Tinnitus Masker Option Device

- Pathway: 510(k) (Abbreviated)
- Applicant: Magnatone Hearing Aid Corp. Dba Persona Medical
- Decided: Dec 22, 2010 after 386 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: 4 generations back to K974501 (1998). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974751: Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic, General Hearing Instruments, Inc. (1998) Summary page 2.
- K073636: Tinnitus Sound Generator Module, Gn Resound A/S (2008) Summary page 2.
- (no number) GN Resound Live TS BTE, OTE and RIB (RIC) products: named in the summary without a submission number

## Indications for use
The Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists. The target population for this product is primarily the adult population 18 years of age and older. The target group for this product includes individuals reporting tinnitus who can also benefit from an air conduction hearing aid. NOTE: The Evok 900 series Tinnitus Masker Devices are targeted primarily to the adult population over 18 years old. Our User Guide does state this but it also has a statement that reads; "a child with a hearing loss should be directed to an Audiologist for evaluation and rehabilitation". This is not meant to be a contradiction considering the user guide is generic in the general information supplied to the end user. As part of a Tinnitus Management Program, we suggest the following recommendations applicable to clinical settings for all the devices listed above; The Tinnitus Management treatment should include evaluation and recommendations done by a qualified audiologist, otorhinolaryngologists or other licensed hearing healthcare professional. Since tinnitus can be associated with a number of auditory conditions, the audiologic evaluation can yield extensive information regarding the possible cause for the tinnitus and options for a successful Tinnitus Management treatment.

Source page: https://510kreport.com/device/K093715
Methodology: https://510kreport.com/methodology