# K974751: Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-Cic

- Pathway: 510(k) (Traditional)
- Applicant: General Hearing Instruments, Inc.
- Decided: Mar 6, 1998 after 77 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K982451: Ttcghi-T and TTCTN3-T-T (1999), 2 descendants of its own
- K132965: Solace Sound Generators (2014), 0 descendants of its own
- K093715: Evok 900 Series Hearing Aid/Tinnitus Masker Option Device (2010), 0 descendants of its own
- K083488: Jump S+ TRT, Jump Cic TRT, Jump S TRT, Jump C TRT (2009), 0 descendants of its own
- K031624: Tinnitus RX (2003), 0 descendants of its own

## Indications for use
No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a'lpw tolerance to loudness or when thg patient's response. to tinnitus is characterized by intolerence. ) Specifically the inability to cope with head noises, anxiety, depression or the inability to function 1in daily life activities.. . When cosmetics are not an issue. No hearing loss or a mild to severe high frequency nearing loss where the patient exhibits a low tolerance to loudness or when the patient's response. to tinnitus is characterized by intolerence. . Specifically the inability to cope with head noises, anxiety, depression or the inability to function 1in daily life activities. When cosmetics are an issue. No hearing loss or a mild to severe @igh frequency nearing loss where the patient exhibits allow tolerance to loudness or when the patient’s response. to tinnitus is characterized by intolerence. _ Specifically the inability to cope with head noises, anxiety, depression or the inability to function 1in daily life activities. When cosmetics are a major issue.

Source page: https://510kreport.com/device/K974751
Methodology: https://510kreport.com/methodology