Cochlear Americas: FDA clearances and approvals
Cochlear Americas has 21 FDA 510(k) clearances (first 2008, latest 2026), plus 6 PMA decisions, across 7 product codes in 2 review panels. Median 510(k) review time: 118 days. Since 2017 its median was 116 days, against 136 days for all cleared 510(k)s in the same product codes. openFDA lists 5 product recalls by a recalling firm named Cochlear Americas.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 163 |
| 2013 | 2 | 128 |
| 2014 | 0 | — |
| 2015 | 3 | 133 |
| 2016 | 2 | 72 |
| 2017 | 1 | 56 |
| 2018 | 1 | 135 |
| 2019 | 2 | 119 |
| 2020 | 0 | — |
| 2021 | 2 | 148 |
| 2022 | 1 | 118 |
| 2023 | 1 | 84 |
| 2024 | 1 | 90 |
| 2025 | 0 | — |
| 2026 | 1 | 114 |
Review time against the same product codes
Since 2017, Cochlear Americas's cleared 510(k)s took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 136 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LXB | Hearing Aid, Bone Conduction | 12 | 12 |
| PFO | Active Implantable Bone Conduction Hearing System | 5 | 5 |
| MCM | Implant, Cochlear | 4 | 0 |
| MAH | Hearing Aid, Bone Conduction, Implanted | 3 | 3 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 1 | 1 |
| MHE | Implant, Auditory Brainstem | 1 | 0 |
| PGQ | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | 1 | 0 |
Review panels
- Ear, Nose and Throat (26)
- General Hospital (1)
Most recent Cochlear Americas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260902 | Cochlear Osia® 3(I) Sound Processor;Cochlear Osia® 3 Sound Processor;Cochlear Osia® 3 Charger;Cochlear Osia® 3 Aqua+;Cochlear Osia® Fitting Software 3;Cochlear Osia® Smart App;Cochlear Osia® System | PFO | 2026-07-10 | 114 |
| K240155 | Cochlear Osia System | PFO | 2024-04-18 | 90 |
| K231604 | Instrument Case | KCT | 2023-08-24 | 84 |
| K220922 | Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit | PFO | 2022-07-27 | 118 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | LXB | 2021-09-29 | 83 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | LXB | 2021-02-23 | 214 |
| K191921 | Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments | PFO | 2019-11-15 | 120 |
| K190589 | Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments | PFO | 2019-07-03 | 118 |
| K182116 | BA310 Abutment, BIA310 Implant/Abutment | MAH | 2018-12-19 | 135 |
| K171088 | Cochlear Baha SoundArc | LXB | 2017-06-07 | 56 |
11 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130016 | PMA | NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM | 2014-03-20 |
| P000015 | PMA | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM | 2000-10-20 |
| P970051 | PMA | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | 1998-06-25 |
| P890027 | PMA | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN | 1990-06-27 |
| P840024 | PMA | NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI | 1985-10-31 |
Recalls
5 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2018-12-18.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Cochlear Americas's product codes (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)
Frequently asked questions
How many FDA 510(k) clearances does Cochlear Americas have?
Cochlear Americas has 21 FDA 510(k) clearances (first 2008, latest 2026), plus 6 PMA decisions, across 7 product codes in 2 review panels.
How long does FDA take to clear Cochlear Americas's 510(k)s?
The median time from FDA receipt to decision across Cochlear Americas's cleared 510(k)s is 118 days. Since 2017: 116 days, versus 136 days for all cleared 510(k)s in the same product codes.
What devices does Cochlear Americas make?
Its most frequent FDA product codes are LXB (Hearing Aid, Bone Conduction, 12); PFO (Active Implantable Bone Conduction Hearing System, 5); MCM (Implant, Cochlear, 4).
Has Cochlear Americas had device recalls?
openFDA lists 5 product recalls in 5 recall events by a recalling firm whose name matches Cochlear Americas; the most recent began 2018-12-18. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 21 Cochlear Americas clearances with predicates and recalls
- Run predicate analysis for product code LXB, Cochlear Americas's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.