Skip to content

SoniTon

by SBO Hearing A/S 1,000+ variants

Ref 230433Model HI (BTE)

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Overview

The SoniTon device is a Class IIa medical device used for monitoring and treating hearing loss. It features advanced endocrine disruptor detection, making it an essential tool in the diagnosis and treatment of auditory disorders.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57144640-HI-00052-R8 Basic UDI-DI 05714464030170UDI-DIDate18 Nov 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
HI (BTE), 230433
Primary DI / UDI-DI
05714464030170
Basic UDI-DI
57144640-HI-00052-R8
EMDN Code
Y2145060102 Behind-the-ear hearing aids with receiver in the canal (ric, rite)
Device Class
Class IIa
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000001270

Related devices

Category: Air-conduction hearing aid, receiver-in-canal

Other devices from Sbo Hearing A/S

See all devices from Sbo Hearing A/S →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No