FDA product code LXB: Hearing Aid, Bone Conduction
LXB is the FDA product code for hearing aid, bone conduction. It is a Class II device, regulated under 21 CFR 874.3302 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 53 510(k) submissions under LXB, 6 in the last five years, from 21 different applicants. The average 510(k) review took 120 days (median 105); 172 days on average over the last three years. FDA has posted 7 recalls for LXB devices.
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Bone Conduction |
| Device class | Class II |
| Regulation | 21 CFR 874.3302 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LXB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 56 |
| 2018 | 1 | 256 |
| 2019 | 1 | 59 |
| 2021 | 4 | 98 |
| 2025 | 2 | 168 |
| 2026 | 4 | 176 |
Compare with all 510(k) review times · Search every LXB clearance
Top LXB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cochlear Americas | 12 | 2021-09-29 |
| Oticon Medical AB | 8 | 2021-12-16 |
| Xomed, Inc. | 6 | 1988-11-30 |
| Sophono, Inc. | 5 | 2016-06-16 |
| Entific Medical Systems, Inc. | 5 | 2004-08-26 |
16 more applicants have LXB clearances. See the full list in Caduvo.
Most recent LXB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253431 | Shokz Health Global Limited | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | 2026-08-19 | 322 |
| K254296 | Sounduct | Ossiclear (Ossiclear System) | 2026-07-22 | 203 |
| K260452 | Zdeer Technology (Henan) Co., Ltd. | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | 2026-06-15 | 124 |
| K261256 | Shenzhen Magnet Technology Co., Ltd. | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | 2026-06-11 | 56 |
| K250215 | Cochlear | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | 2025-05-29 | 125 |
Recalls for LXB devices
7 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-12-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LXB?
LXB is the FDA product code for hearing aid, bone conduction. It is a Class II device, regulated under 21 CFR 874.3302 and reviewed by the Ear, Nose and Throat panel.
What device class is LXB?
Class II, regulation 21 CFR 874.3302. Typical premarket route: 510(k).
How long does a 510(k) take for product code LXB?
Across 53 cleared submissions the average was 120 days from receipt to decision (median 105).
Which companies have the most LXB clearances?
Cochlear Americas (12); Oticon Medical AB (8); Xomed, Inc. (6); Sophono, Inc. (5); Entific Medical Systems, Inc. (5).
Have LXB devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2018-12-18.
Next steps
- Run an FDA pathway report with predicate devices for product code LXB
- Run a recall and safety report across every LXB manufacturer
- Watch product code LXB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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