Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only. This page is not medical advice and does not replace the guidance of a patient’s speech-language pathologist or surgical team.
Short answer
An electrolarynx is a battery-powered device held against the skin near the voicebox that produces sound for a person who no longer has a larynx. FDA classifies it as a Class I device under 21 CFR 874.3375. A voice prosthesis is a different thing: ASHA lists the electrolarynx and the tracheoesophageal (TEP) voice prosthesis as two separate alaryngeal speech options after total laryngectomy.
Definition and scope
The Code of Federal Regulations defines the device as a “battery-powered artificial larynx”: an externally applied device intended for use in the absence of the larynx to produce sound. When it is held against the skin in the area of the voicebox, it generates mechanical vibrations that resonate in the oral and nasal cavities and can be modulated by the tongue and lips, allowing the production of speech (21 CFR 874.3375(a), checked 2026-10-30).
In FDA’s device classification database the same device appears as “Larynx, Artificial (Battery-Powered)”, product code ESE, device class 1, in the Ear, Nose, Throat review panel (openFDA classification record, checked 2026-10-30). The regulation sits in 21 CFR Part 874, Subpart D, Prosthetic Devices, but the device it describes is applied externally.
How it is used in practice
ASHA’s Practice Portal on head and neck cancer describes communication rehabilitation after surgical removal of the larynx as targeting “the production of speech and voice using a sound source other than the larynx.” It says this most often includes an electrolarynx, esophageal speech, and/or tracheoesophageal speech (ASHA Practice Portal, Head and Neck Cancer, checked 2026-10-30).
The same page places the electrolarynx inside a speech-language pathologist’s assessment: the SLP assesses all appropriate communication modalities, which may include trials of esophageal speech or use of an electrolarynx. Training in the care and use of a tracheoesophageal voice prosthesis is listed as a separate SLP activity.
Electrolarynx vs voice prosthesis and other alaryngeal speech options
The table summarises ASHA’s description of the options. It describes the options; it does not rank them or say which suits any individual.
| Option | What ASHA says |
|---|---|
| Electrolarynx | One of the three options most often used after laryngectomy. Assessment may include trials of electrolarynx use. |
| Tracheoesophageal (TEP) speech with a voice prosthesis | One of the three options most often used. The SLP’s role includes training in the care and use of the voice prosthesis. |
| Esophageal speech | One of the three options most often used. Assessment may include trials of esophageal speech. |
| Buccal speech and pharyngeal speech | Two other types of alaryngeal speech. ASHA says their use as a primary method after laryngectomy is rare in the United States, but they are still used in certain cultures and other parts of the world. |
The core distinction is where the sound source comes from. The electrolarynx is an external device defined by the regulation above. A voice prosthesis is a separate item that ASHA describes in the context of tracheoesophageal voice, with its own care and use training. For detail on candidacy and treatment, ASHA points readers to its resource “Communication After Total Laryngectomy.”
Where it matters for labs, clinics and supply decisions
Regulatory status
Under 21 CFR 874.3375(b) the battery-powered artificial larynx is Class I (general controls). The regulation states that the device is exempt from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 874.9. For background on the pathway it is exempt from, see the CASRAI guide to FDA 510(k) premarket notification and the overview of FDA device classification, 510(k) and PMA pathways.
Specification checklist for staff handling the device record
These items come straight from the regulation and FDA’s classification entry, so they can be checked against a product listing without relying on any claim about performance.
- Device name and product code: “Larynx, Artificial (Battery-Powered)”, ESE.
- Regulation number and class: 21 CFR 874.3375, Class I.
- Application: externally applied, held against the skin near the voicebox (not implanted).
- Power: the regulation names the device battery-powered, so the power source belongs in the item’s specification.
- Identification: devices are identified by Unique Device Identifier; see UDI for medical devices.
The nearest related CASRAI pages are the plain-language guides to tracheostomy tubes and ENT surgical instruments and their FDA classification, and the definition of a medical device.
Common misunderstandings
“An electrolarynx and a voice prosthesis are the same thing.”
They are not. ASHA lists them as distinct options, and the regulation for the electrolarynx describes an externally applied device.
“Class I means no oversight.”
Class I devices are subject to general controls. The 510(k) exemption in 874.3375(b) applies only subject to the limitations in 21 CFR 874.9.
“There is one standard way to speak after laryngectomy.”
ASHA describes several alaryngeal speech types, and the choice is part of an individual clinical assessment.
FAQ
What is the difference between an electrolarynx and a voice prosthesis?
An electrolarynx is a battery-powered device held against the skin that produces sound when the larynx is absent (21 CFR 874.3375). A tracheoesophageal voice prosthesis is a separate option ASHA lists alongside it, and ASHA describes SLP training in its care and use.
How does FDA classify an electrolarynx?
As Class I (general controls) under 21 CFR 874.3375, product code ESE.
Does an electrolarynx need a 510(k)?
The regulation says the device is exempt from premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 874.9.
Who assesses which speech option is used?
According to ASHA, the speech-language pathologist assesses the communication modalities, which may include trials of esophageal speech or use of an electrolarynx.
Sources
- 21 CFR 874.3375, Battery-powered artificial larynx, law.cornell.edu/cfr/text/21/874.3375, checked 2026-10-30.
- openFDA device classification record, regulation number 874.3375, api.fda.gov, data updated 2026-10-19, checked 2026-10-30.
- ASHA Practice Portal, Head and Neck Cancer, asha.org, checked 2026-10-30.
