Chrysalis Intelligence · Product Codes · LXB

LXB · Unclassified

9 clearances · 7 unique sponsors

Device class
Regulation —
Total clearances
9
2021-02-23 → 2026-07-22
Last 12 months
3
Unique sponsors
7
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Cochlear Americas 2 0 2021-09-29
Oticon Medical AB 2 0 2021-12-16
Bhm-Tech Produktionsgesellschaft Mbh 1 0 2025-04-25
Cochlear 1 0 2025-05-29
Shenzhen Magnet Technology Co., Ltd. 1 1 2026-06-11
Zdeer Technology (Henan) Co., Ltd. 1 1 2026-06-15
Sounduct 1 1 2026-07-22
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
L3030 HCPCS Foot, insert, removable, formed to patient foot, each ✓ CMS-verified description High Hearing aid, bone conduction, any type
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-22 K254296 Sounduct Ossiclear (Ossiclear System)
2026-06-15 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)
2026-06-11 K261256 Shenzhen Magnet Technology Co., Ltd. Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
2025-05-29 K250215 Cochlear Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand
2025-04-25 K243041 Bhm-Tech Produktionsgesellschaft Mbh contact forte Alpha
2021-12-16 K213733 Oticon Medical AB Ponto 5 SuperPower
2021-09-29 K212136 Cochlear Americas Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
2021-08-10 K211640 Oticon Medical AB Ponto 5 Mini
2021-02-23 K202048 Cochlear Americas Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App