FDA 510(k) ClearanceESD
HI-69E, HI-69N, HI-69P
FDA 510(k) K974129 · Rockwin Corp.
- 510(k) number
- K974129
- Device name
- HI-69E, HI-69N, HI-69P
- Applicant
- Rockwin Corp.
- Product code
- ESD
- Decision
- Substantially Equivalent
- Decision date
- 1997-12-12
- Device class
- Class 1
- Regulation number
- 874.3300
- Advisory committee
- Ear, Nose, Throat
- Medical specialty
- Ear, Nose, Throat
Candidate predicate devices
Other devices cleared under product code ESD — the same regulatory device type, and therefore candidate predicates for a substantial-equivalence comparison. Confirm each predicate is legally marketed before relying on it.
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | 2024-04-11 |
| K130790 | LYRIC2 | Phonak, LLC | 2013-06-27 |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | 2008-05-08 |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | 2002-11-19 |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | 2001-04-24 |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | 1999-03-12 |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | 1998-03-06 |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | 1998-01-20 |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | 1998-01-12 |
| K974069 | OPUS 2 - CANAL SERIES (ITC) | Bernafon-Maico, Inc. | 1997-12-15 |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. | 1997-12-15 |
| K974152 | OPUS 2 - COMPLETELY-IN-CANAL SERIES (CIC) | Bernafon-Maico, Inc. | 1997-12-15 |
Building a 510(k) around this device type?
Assyro turns predicate research into a substantial-equivalence comparison and an eSTAR-ready 510(k) workflow — so predicate strategy, testing evidence, and labeling stay aligned before FDA review.