Advanced Bionics: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Advanced Bionics”, plus 2 PMA decisions, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCM | Implant, Cochlear | 2 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960058 | PMA | CLARION MULTI-STRATEGY COCHLEAR IMPLANT | 1997-06-26 |
| P940022 | PMA | CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT | 1996-03-22 |
Recalls
35 product recalls in 23 recall events; 4 initiated in the last five years. Most recent: 2026-04-30.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Advanced Bionics is the lead sponsor of 8 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05859568: Baseline Performance and Fitting Parameters for Sonova Products (Enrolling by invitation, started 2023-04-17)
- NCT05034731: Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System (Completed, started 2021-08-18)
- NCT04237207: Clinical Evaluation of a Cochlear Implant Sound Processor (Completed, started 2019-12-17)
- NCT05488535: Non-significant Risk Study of a Cochlear Implant Headpiece (Completed, started 2019-02-28)
- NCT02811549: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss (Completed, started 2016-11-07)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Advanced Bionics (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via MCM)
- L8628 — Cochlear implant, external controller component, replacement (via MCM)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via MCM)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via MCM)
- L8627 — Cochlear implant, external speech processor, component, replacement (via MCM)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Orthopaedic Solutions, Inc. (24 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Bionics?
FDA lists 0 510(k) clearances under the applicant name “Advanced Bionics”, plus 2 PMA decisions, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Advanced Bionics?
The most frequent FDA product codes under this applicant name are MCM (Implant, Cochlear, 2).
Next steps
- See all 0 Advanced Bionics clearances with predicates and recalls
- Run predicate analysis for product code MCM, Advanced Bionics's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.