TRANSEAR BONE CONDUCTION HEARING AID— 510(k) K062404
Substantially EquivalentEar Technology Corp.
FDA 510(k) clearance K062404 for TRANSEAR BONE CONDUCTION HEARING AID, Substantially Equivalent on 2006-09-08. Applicant: Ear Technology Corp.. Device class: 2.
Clearance details
- Applicant
- Ear Technology Corp.
- Product code
- Code LXB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3302
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Johnson City, TN, US
Recent devices under product code LXB
view all- K253431 — Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
- K254296 — Ossiclear (Ossiclear System)
- K260452 — 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)
- K261256 — Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
- K250215 — Baha 7 Sound Processor +4 more
More clearances from Ear Technology Corp.
view allAdverse events under product code LXB
product code LXB- Injury
- 2,334
- Total
- 2,334
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.