Written and maintained by CASRAI Editorial Board
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General product and regulatory information only, not medical advice. Questions about a specific patient’s voice prosthesis belong with the treating surgeon or speech-language pathologist.
Short answer
Blom-Singer and Provox are brand names of tracheoesophageal voice prostheses, devices used for voice rehabilitation after the larynx has been removed. In FDA’s records both brands sit under the same product code, EWL, and the same regulation, 21 CFR 874.3730, which is a Class II (special controls) device type. The brand does not change the regulatory category, so the useful way to compare them is to read each product’s own FDA and device-identifier record.
Definition and scope
The regulation that FDA applies to these devices, 21 CFR 874.3730 (checked 2026-10-30), is titled “Laryngeal prosthesis (Taub design).” It identifies the device as one “intended to direct pulmonary air flow to the pharynx in the absence of the larynx, thereby permitting esophageal speech,” interposed between openings in the trachea and the esophagus. Under paragraph (b) the device is Class II (special controls), and a version that is a voice amplification device is exempt from premarket notification subject to the limits in 21 CFR 874.9.
FDA’s product classification database lists code EWL as “Prosthesis, Laryngeal (Taub)” in the Ear, Nose and Throat panel, device class 2, with 510(k) as the submission type. Note the naming: the regulation and code carry the Taub design name, yet the Blom-Singer and Provox records discussed below are filed under the same code. This guide is about the device category and its public records; it does not cover how a prosthesis is placed, changed or cleaned.
How the category is described in public records
The U.S. National Library of Medicine’s AccessGUDID record for the InHealth Technologies Blom-Singer Classic (device identifier 00813307011033, checked 2026-10-30) assigns the Global Medical Device Nomenclature term “Tracheoesophageal speech valve, indwelling.” The GMDN definition describes a device for a surgically created tracheo-oesophageal fistula after total laryngectomy that provides voice restoration, has a one-way valve that protects the airway during swallowing, and is a single-use device that a clinician inserts and replaces as needed.
That description differs from the regulation text, which describes a Taub-design device that the patient may remove and replace themselves. The two documents describe different device concepts under one regulatory heading, which is why a product’s own record matters more than the shared code.
For readers new to related airway and voice devices, the CASRAI guides on the electrolarynx versus a voice prosthesis, the tracheostomy tube and ENT surgical instruments and their FDA classification cover neighbouring equipment.
Two sourced examples: Blom-Singer Classic and Provox Vega
| Item | Blom-Singer Classic (InHealth) | Provox Vega (Atos) |
|---|---|---|
| Public record | AccessGUDID, DI 00813307011033 | FDA 510(k) K090455 |
| Company named in record | Freudenberg Medical, LLC (brand InHealth Technologies; Blom-Singer; Classic) | Atos Medical AB (applicant) |
| Model identifier | IN 2010-SO | Models 8130-8135 |
| Product code and regulation | EWL, 21 CFR 874.3730 (code listed in the record) | EWL, 21 CFR 874.3730 |
| FDA decision | Not applicable to this record type | Substantially Equivalent, 5 June 2009, traditional 510(k) |
| Single use | Yes | Not a field in the 510(k) entry |
| Sterility fields | Packaged sterile: No; sterilization before use: No | Not a field in the 510(k) entry |
| Prescription status | Rx | Not a field in the 510(k) entry |
| MRI labeling | “Labeling does not contain MRI Safety Information” | Not a field in the 510(k) entry |
Sources: AccessGUDID record and the FDA 510(k) database entry for K090455, both checked 2026-10-30. The empty cells are a feature of the two record types, not a difference between the products: a 510(k) listing and a device-identifier listing hold different fields.
Where it matters for labs, clinics and supply decisions
Staff who maintain device records, formularies or supplier files can use the public records to confirm what a product is before it is entered into a catalogue. A checklist drawn from the fields above:
- Applicant or company. The 510(k) names the applicant (Atos Medical AB for K090455); the GUDID record names the labeler company (Freudenberg Medical, LLC for the Blom-Singer Classic record). These can differ from the brand on the carton.
- Model and device identifier. Match the model number (for example 8130-8135 or IN 2010-SO) to the record rather than to a brand family name.
- Product code and regulation. Confirm EWL and 21 CFR 874.3730, and the Class II designation.
- Single-use and sterility fields. GUDID records whether a device is single-use, packaged sterile, and needs sterilization before use. For the Blom-Singer Classic record these read Yes, No and No.
- Prescription status. The same record lists the device as prescription (Rx).
- MRI labeling. GUDID states whether the labeling carries MRI safety information; for this record it does not.
- Kit contents. The record flags the Blom-Singer Classic as a kit and also lists a separate GMDN term, “Airway device cleaning utensil, invasive,” defined as a non-sterile hand-held device for cleaning an in-situ airway device. Check what is in the package against the record.
Adverse events involving devices are handled through FDA’s reporting system; see Medical Device Reporting (MDR) and the background on the Medical Device Amendments of 1976, which set up the device classes referred to here.
Common misunderstandings
Provox and Blom-Singer are different regulatory categories
No. Both are filed under product code EWL and 21 CFR 874.3730 in the records cited here. Differences between the brands are differences between models and manufacturers, not between FDA categories.
A “Taub design” name means the device is a Taub device
The name belongs to the regulation title and the product code. The records for current brand-name products are filed under it, but the regulation text itself describes a patient-removable device, whereas the GMDN definition for the indwelling type describes clinician replacement. Read the record for the specific product.
FDA clearance means a product is the right choice
A “Substantially Equivalent” decision, such as the one recorded for K090455, is a statement about equivalence to a predicate device in a regulatory review. It is not a ranking, and it does not say which product suits any individual.
One record covers every model in a brand family
Each model has its own record or clearance. The Provox Vega entry above covers models 8130-8135 only; other Provox models, such as the Activalve, have their own listings to check.
Frequently asked questions
What is a Blom-Singer?
Blom-Singer is a brand of tracheoesophageal voice prosthesis made by InHealth Technologies, a device used for voice rehabilitation after the larynx has been removed. In the AccessGUDID record cited above, the Blom-Singer Classic is a single-use, prescription device.
Is Provox the same as Blom-Singer?
They are different brands from different companies (Atos Medical for Provox, InHealth Technologies for Blom-Singer), but the records cited here file both under FDA product code EWL and 21 CFR 874.3730.
What is the Provox Vega?
The Provox Vega is an Atos Medical model line (models 8130-8135) that FDA cleared under 510(k) K090455 with a Substantially Equivalent decision on 5 June 2009.
Where can the official record for a specific prosthesis be found?
Search the FDA 510(k) database by K number and AccessGUDID by device identifier, as in the Sources section below.
Sources
- 21 CFR 874.3730, Laryngeal prosthesis (Taub design), Legal Information Institute copy of the eCFR, checked 2026-10-30.
- FDA Product Classification, code EWL, and 510(k) K090455 (Provox Vega, Atos Medical AB, decided 2009-06-05), U.S. Food and Drug Administration, checked 2026-10-30.
- AccessGUDID: InHealth Technologies Blom-Singer Classic, U.S. National Library of Medicine, checked 2026-10-30.
