Cochlear Americas: FDA filings under this applicant name

FDA lists 21 510(k) clearances under the applicant name “Cochlear Americas” (first 2008, latest 2026), plus 6 PMA decisions, across 7 product codes in 2 review panels. Median 510(k) review time under this name: 118 days. Since 2017 the median was 116 days, against 136 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Cochlear Americas 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

Review panels

• Ear, Nose and Throat (26)
• General Hospital (1)

Most recent Cochlear Americas 510(k) clearances

11 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

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 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.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cochlear Americas (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.

• Cochlear (3 510(k)s)
• Cochlear Bone Anchored Systems AB (2 510(k)s)
• Cochlear Laboratories, Ltd. (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Cochlear Americas?

FDA lists 21 510(k) clearances under the applicant name “Cochlear Americas” (first 2008, latest 2026), plus 6 PMA decisions, across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Cochlear Americas?

The median time from FDA receipt to decision across 510(k)s cleared under the name Cochlear Americas is 118 days. Since 2017: 116 days, versus 136 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Cochlear Americas?

The most frequent FDA product codes under this applicant name are LXB (Hearing Aid, Bone Conduction, 12); PFO (Active Implantable Bone Conduction Hearing System, 5); MCM (Implant, Cochlear, 4).

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. 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.

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