Direct comparison
Bone Anchored Hearing Aid vs Cochlear Implant
Bone anchored hearing aid vs cochlear implant: how each sends sound, their parts, and FDA class and product code (LXB, 21 CFR 874.3302 vs MCM).
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Last updated
How do Bone-conduction (bone-anchored) hearing aid and Cochlear implant compare side by side?
The table below compares Bone-conduction (bone-anchored) hearing aid and Cochlear implant across 10 dimensions, from what it is to when each is the one the sources describe.
Side-by-side comparison
| Dimension | Bone-conduction (bone-anchored) hearing aid | Cochlear implant |
|---|---|---|
| What it is | FDA calls the category a "bone-conduction hearing aid": a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the inner ear through the skull (21 CFR 874.3302). | A small, complex electronic device that can help provide a sense of sound to a person who is profoundly deaf or severely hard-of-hearing (NIDCD). |
| How sound reaches the hearing system | Through the skull. The prescription active implantable version conveys amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone (21 CFR 874.3340). | Bypasses damaged portions of the ear and directly stimulates the auditory nerve; the brain recognizes the signals as sound (NIDCD). |
| Named parts | The regulation names an external sound processor as a non-implantable component (874.3302). The active implantable system is an implanted transducer, implanted electronics and an audio processor (874.3340). | Microphone, speech processor, transmitter, receiver and stimulator, and electrode array. One portion sits behind the ear and a second is surgically placed under the skin (NIDCD). |
| FDA device class | Class II (21 CFR 874.3302). The active implantable bone conduction system is Class II with special controls (874.3340). | Class 3 in the FDA product classification record for code MCM, "Implant, Cochlear". |
| FDA product code | LXB, "Hearing Aid, Bone Conduction", regulation number 874.3302. | MCM, "Implant, Cochlear"; the record lists no regulation number. |
| Implant flag in the FDA record | LXB: implant flag "N". | MCM: implant flag "Y". |
| Hearing-aid labeling rule | Non-implantable components, such as the external sound processor, are subject to 21 CFR 801.422 (874.3302). | 801.422 is cited in the bone-conduction regulation; the NIDCD page does not apply it to cochlear implants. |
| Hearing loss the sources name | 874.3302: "impaired hearing". The active implantable system (874.3340) is intended for conductive or mixed hearing losses. | Profoundly deaf or severely hard-of-hearing (NIDCD). The device does not restore normal hearing; hearing through an implant is different and takes time to learn or relearn. |
| Dates in the sources | The 874.3302 classification is published at 87 FR 50762, Aug. 17, 2022. | FDA first approved cochlear implants in the mid-1980s for adults; since 2020 for eligible children beginning at 9 months of age (NIDCD). |
| When each is the one the sources describe | Impaired hearing handled by conducting sound through the skull; for the implanted system, conductive or mixed hearing loss. Candidacy is decided by an audiologist or ENT physician. | Profound or severe hearing loss, where the device stimulates the auditory nerve directly. Candidacy is decided by an audiologist or ENT physician. |
Sources
- 21 CFR 874.3302 and 874.3340 (eCFR/LII)
- FDA classification code LXB. Read 2026-10-30
- NIDCD, Cochlear Implants (nidcd.nih.gov/health/cochlear-implants)
- FDA classification code MCM. Read 2026-10-30
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Common questions
Common questions about Bone-conduction (bone-anchored) hearing aid vs Cochlear implant
Is a bone-anchored hearing aid a cochlear implant?
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No. NIDCD describes a cochlear implant as a device that bypasses damaged portions of the ear and directly stimulates the auditory nerve. The FDA bone-conduction regulations describe conducting sound through the skull to the inner ear or cochlea. FDA also lists them under different product codes and classes: LXB (Class II) and MCM (Class 3).
Is a bone-conduction device a hearing aid under FDA rules?
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In the regulation's wording, yes. 21 CFR 874.3302 is titled "Bone-conduction hearing aid" and classifies it as Class II, with product code LXB. Its non-implantable parts, such as the external sound processor, are subject to 21 CFR 801.422. The active implantable bone conduction hearing system is a separate prescription device under 21 CFR 874.3340.
