Singapore HSA registration DE0507358

Sonova Phonak Audeo L Hearing Aids

Singapore·CLASS B·Sonova AG·Registered October 10, 2022

Device classification

Device Class: CLASS B
Medical Speciality Area: Ear, Nose & Throat

Registration information

Registration Number: DE0507358
Registration Date: October 10, 2022
Change Notification Approval Date: November 21, 2023
Retention Due Date: October 09, 2025

Product description

The hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing. The Phonak Tinnitus Balance software feature is intended for use by people with tinnitus who also desire amplification. It provides supplementary noise stimulation which can help defocus the user's attention from their tinnitus. General clinical indications for the use of hearing aids, charger and Tinnitus software feature are: - Presence of hearing loss - Uni- or bilateral - Conductive, sensorineural or mixed - Mild to profound - Presence of a chronic tinnitus

Product Owner

Name: Sonova AG
Short Name: Sonova AG
Address: Laubisrutistrasse 28, 8712 Stafa, SWITZERLAND

Registrant

Name: SONOVA SINGAPORE PTE. LTD.
Address: 8 KALLANG AVENUE, APERIA, #13-08, SINGAPORE 339509

Importer

Name: SONOVA SINGAPORE PTE. LTD.
Address: 21 MEDIA CIRCLE, INFINITE STUDIOS, #07-01/04, SINGAPORE 138562

Model information

Model Name(s): Phonak Audeo L30-R Phonak Audeo L30-R Phonak Audeo L30-R Phonak Audeo L30-R Phonak Audeo L30-R Phonak Audeo L30-R Phonak Audeo L30-R Phonak Audeo L30-R AUDÉO L-R 30 (electric green) AUDÉO L-R 30 (caribbean pirate) AUDÉO L-R 30 (precious pink) Phonak Audeo L50-R Phonak Audeo L50-R Phonak Audeo L50-R Phonak Audeo L50-R Phonak Audeo L50-R Phonak Audeo L50-R Phonak Audeo L50-R Phonak Audeo L50-R AUDÉO L-R 50 (electric green) AUDÉO L-R 50 (caribbean pirate) AUDÉO L-R 50 (precious pink) Phonak Audeo L70-R Phonak Audeo L70-R Phonak Audeo L70-R Phonak Audeo L70-R Phonak Audeo L70-R Phonak Audeo L70-R Phonak Audeo L70-R Phonak Audeo L70-R AUDÉO L-R 70 (electric green) AUDÉO L-R 70 (caribbean pirate) AUDÉO L-R 70 (precious pink) Phonak Audeo L90-R Phonak Audeo L90-R Phonak Audeo L90-R Phonak Audeo L90-R Phonak Audeo L90-R Phonak Audeo L90-R Phonak Audeo L90-R Phonak Audeo L90-R AUDÉO L-R 90 (electric green) AUDÉO L-R 90 (caribbean pirate) AUDÉO L-R 90 (precious pink) Phonak Audeo L50-RT Phonak Audeo L50-RT Phonak Audeo L50-RT Phonak Audeo L50-RT Phonak Audeo L50-RT Phonak Audeo L50-RT Phonak Audeo L50-RT Phonak Audeo L50-RT AUDÉO L-RT 50 (electric green) AUDÉO L-RT 50 (caribbean pirate) AUDÉO L-RT 50 (precious pink) Phonak Audeo L70-RT Phonak Audeo L70-RT Phonak Audeo L70-RT Phonak Audeo L70-RT Phonak Audeo L70-RT Phonak Audeo L70-RT Phonak Audeo L70-RT Phonak Audeo L70-RT AUDÉO L-RT 70 (electric green) AUDÉO L-RT 70 (caribbean pirate) AUDÉO L-RT 70 (precious pink) Phonak Audeo L90-RT Phonak Audeo L90-RT Phonak Audeo L90-RT Phonak Audeo L90-RT Phonak Audeo L90-RT Phonak Audeo L90-RT Phonak Audeo L90-RT Phonak Audeo L90-RT AUDÉO L-RT 90 (electric green) AUDÉO L-RT 90 (caribbean pirate) AUDÉO L-RT 90 (precious pink) Phonak Audeo L70-RL Phonak Audeo L70-RL Phonak Audeo L70-RL Phonak Audeo L70-RL Phonak Audeo L70-RL Phonak Audeo L70-RL Phonak Audeo L70-RL Phonak Audeo L70-RL AUDÉO L-RL 70 (electric green) AUDÉO L-RL 70 (caribbean pirate) AUDÉO L-RL 70 (precious pink) Phonak Audeo L90-RL Phonak Audeo L90-RL Phonak Audeo L90-RL Phonak Audeo L90-RL Phonak Audeo L90-RL Phonak Audeo L90-RL Phonak Audeo L90-RL Phonak Audeo L90-RL AUDÉO L-RL 90 (electric green) AUDÉO L-RL 90 (caribbean pirate) AUDÉO L-RL 90 (precious pink) Phonak Audeo L-R Trial Phonak Audeo L-RT Trial Phonak Audeo L-RL Trial Phonak Audeo L30-RT Phonak Audeo L30-RT Phonak Audeo L30-RT Phonak Audeo L30-RT Phonak Audeo L30-RT Phonak Audeo L30-RT Phonak Audeo L30-RT Phonak Audeo L30-RT AUDÉO L-RT 30 (electric green) AUDÉO L-RT 30 (caribbean pirate) AUDÉO L-RT 30 (precious pink) Phonak Audeo L30-RL Phonak Audeo L30-RL Phonak Audeo L30-RL Phonak Audeo L30-RL Phonak Audeo L30-RL Phonak Audeo L30-RL Phonak Audeo L30-RL Phonak Audeo L30-RL AUDÉO L-RL 30 (electric green) AUDÉO L-RL 30 (caribbean pirate) AUDÉO L-RL 30 (precious pink) Phonak Audeo L50-RL Phonak Audeo L50-RL Phonak Audeo L50-RL Phonak Audeo L50-RL Phonak Audeo L50-RL Phonak Audeo L50-RL Phonak Audeo L50-RL Phonak Audeo L50-RL AUDÉO L-RL 50 (electric green) AUDÉO L-RL 50 (caribbean pirate) AUDÉO L-RL 50 (precious pink) Phonak Target myPhonak
Model Identifier(s): 050-0874-H0 050-0874-P1 050-0874-P3 050-0874-P4 050-0874-P5 050-0874-P6 050-0874-P7 050-0874-P8 050-0874-Q2 050-0874-Q3 050-0874-T3 050-0875-H0 050-0875-P1 050-0875-P3 050-0875-P4 050-0875-P5 050-0875-P6 050-0875-P7 050-0875-P8 050-0875-Q2 050-0875-Q3 050-0875-T3 050-0888-H0 050-0888-P1 050-0888-P3 050-0888-P4 050-0888-P5 050-0888-P6 050-0888-P7 050-0888-P8 050-0888-Q2 050-0888-Q3 050-0888-T3 050-0889-H0 050-0889-P1 050-0889-P3 050-0889-P4 050-0889-P5 050-0889-P6 050-0889-P7 050-0889-P8 050-0889-Q2 050-0889-Q3 050-0889-T3 050-0998-H0 050-0998-P1 050-0998-P3 050-0998-P4 050-0998-P5 050-0998-P6 050-0998-P7 050-0998-P8 050-0998-Q2 050-0998-Q3 050-0998-T3 050-0999-H0 050-0999-P1 050-0999-P3 050-0999-P4 050-0999-P5 050-0999-P6 050-0999-P7 050-0999-P8 050-0999-Q2 050-0999-Q3 050-0999-T3 050-1000-H0 050-1000-P1 050-1000-P3 050-1000-P4 050-1000-P5 050-1000-P6 050-1000-P7 050-1000-P8 050-1000-Q2 050-1000-Q3 050-1000-T3 050-1001-H0 050-1001-P1 050-1001-P3 050-1001-P4 050-1001-P5 050-1001-P6 050-1001-P7 050-1001-P8 050-1001-Q2 050-1001-Q3 050-1001-T3 050-1002-H0 050-1002-P1 050-1002-P3 050-1002-P4 050-1002-P5 050-1002-P6 050-1002-P7 050-1002-P8 050-1002-Q2 050-1002-Q3 050-1002-T3 050-1003-P6 050-1004-P6 050-1005-P6 050-1006-H0 050-1006-P1 050-1006-P3 050-1006-P4 050-1006-P5 050-1006-P6 050-1006-P7 050-1006-P8 050-1006-Q2 050-1006-Q3 050-1006-T3 050-1011-H0 050-1011-P1 050-1011-P3 050-1011-P4 050-1011-P5 050-1011-P6 050-1011-P7 050-1011-P8 050-1011-Q2 050-1011-Q3 050-1011-T3 050-1012-H0 050-1012-P1 050-1012-P3 050-1012-P4 050-1012-P5 050-1012-P6 050-1012-P7 050-1012-P8 050-1012-Q2 050-1012-Q3 050-1012-T3 058-0125-080 088-0022-00063

About this record

Access comprehensive regulatory information for Sonova Phonak Audeo L Hearing Aids in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507358 and owned by Sonova AG. The device was registered on October 10, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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