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Short answer: A BTE (behind-the-ear) hearing aid keeps most of its parts in a small plastic case that rests behind the ear and connects to the ear canal through clear tubing and an earmold or earpiece. In the United States it is a Class I device under 21 CFR 874.3300.
This page describes products and general use; it is not medical advice.
Who uses it: NIDCD states that BTE aids are used by people of all ages for mild to profound hearing loss. Clinic staff, audiologists and supply buyers meet the same product class as the case, tubing, earmold and battery.
What a BTE hearing aid is
The FDA describes BTE aids as having “most parts contained in a small plastic case that rests behind the ear,” with the case “connected to an earmold or an earpiece by a piece of clear tubing.” NIDCD describes the same arrangement: a hard plastic case worn behind the ear and connected to a plastic earmold.
FDA lists these qualities for the style: BTE aids are “easy to clean and handle, and are relatively sturdy,” they can “accommodate various earmold types,” and they are “often chosen for young children.” Earmolds must be replaced as a child grows.
Parts and how sound travels
NIDCD says a hearing aid has three basic parts: a microphone, an amplifier and a speaker. In a BTE aid these sit in the case behind the ear. According to NIDCD, “sound travels from the hearing aid through the earmold and into the ear.”
- Case: the hard plastic housing behind the ear that holds most of the parts (FDA, NIDCD).
- Clear tubing: carries sound from the case to the earmold or earpiece (FDA).
- Earmold or earpiece: sits in the ear. The separate guide on earmold types covers how earmolds are classified.
- Battery: see zinc-air batteries for the cell type used in many hearing aids.
BTE, mini BTE and open-fit compared
FDA and NIDCD each describe variants of the behind-the-ear style. The table names the agency behind each statement.
| Variant | What the agency says | Source |
|---|---|---|
| BTE | Most parts in a small plastic case behind the ear; clear tubing to an earmold or earpiece. | FDA, Types of Hearing Aids |
| Mini BTE (FDA also calls this the receiver-in-canal, or RIC, aid) | “A type of BTE aid that fits behind the ear, but is typically smaller in size.” A narrow tube connects to the ear canal, and it may also use a traditional earmold. Earpieces may reduce the occlusion effect and “increase comfort, reduce feedback, and address cosmetic concerns for many users.” | FDA, Types of Hearing Aids |
| Open-fit | Only a narrow tube is inserted into the ear canal, so the canal can remain open; NIDCD adds that this type is less likely to be damaged by earwax. | NIDCD, Hearing Aids |
How BTE differs from canal styles
A canal aid places its parts in or near the ear canal instead of behind the ear. The completely-in-canal (CIC) hearing aid guide covers that style. This page does not repeat it.
Regulatory status
21 CFR 874.3300 defines an air-conduction hearing aid as “a wearable sound-amplifying device intended to compensate for impaired hearing.” The regulation classifies it as Class I (general controls) and exempts it from premarket notification (510(k)) subject to the limitations in 21 CFR 874.9. It excludes group hearing aids (874.3320), master hearing aids (874.3330) and tinnitus maskers (874.3400). The FDA classification database lists product code ESD under this regulation number. A device is subject to 21 CFR 800.30 or 801.422 as applicable.
Care and handling basics
These are NIDCD’s general care points for hearing aids; follow the manufacturer’s instructions for a specific model.
- Clean hearing aids as instructed; earwax and ear drainage can damage a hearing aid. See hearing aid cleaning tools.
- Keep hearing aids away from heat and moisture; NIDCD also advises turning them off when not in use.
- Avoid hairspray or other hair care products while wearing hearing aids.
- Keep replacement batteries and small aids away from children and pets.
Common mistakes
- Treating “BTE” as one fixed design. FDA separates the standard BTE, the smaller mini BTE and its earpiece options.
- Forgetting that the earmold is a separate item. FDA notes earmolds need to be replaced as a child grows.
FAQ
What does BTE stand for?
Behind-the-ear. The main case rests behind the ear (FDA).
Who wears a BTE hearing aid?
NIDCD says BTE aids are used by people of all ages for mild to profound hearing loss. FDA adds that they are often chosen for young children.
What is an earmold?
It is the piece that connects to the BTE case through tubing and directs sound into the ear (NIDCD, FDA). See earmold types.
What is the difference between a BTE and a mini BTE?
FDA describes the mini BTE as a type of BTE aid that fits behind the ear but is typically smaller, using a narrow tube to connect to the ear canal.
Is a BTE hearing aid a medical device?
Yes. 21 CFR 874.3300 classifies air-conduction hearing aids as Class I medical devices.
Sources
- U.S. Food and Drug Administration, Types of Hearing Aids: https://www.fda.gov/medical-devices/hearing-aids/types-hearing-aids, checked 2026-10-30
- National Institute on Deafness and Other Communication Disorders (NIDCD), Hearing Aids: https://www.nidcd.nih.gov/health/hearing-aids, checked 2026-10-30
- eCFR, 21 CFR 874.3300, Hearing aid: https://www.ecfr.gov/current/title-21/section-874.3300, checked 2026-10-30
- openFDA device classification, product code ESD, checked 2026-10-30: https://api.fda.gov/device/classification.json
