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Sonova Phonak Virto P Hearing Aid (ITE, Digital) - HSA Registration DE0507332

Access comprehensive regulatory information for Sonova Phonak Virto P Hearing Aid (ITE, Digital) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507332 and owned by Sovona AG. The device was registered on October 03, 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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CLASS B
DE0507332
Sonova Phonak Virto P Hearing Aid (ITE, Digital)
HSA Registration Number: DE0507332
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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 and Tinnitus software feature are: Presence of hearing loss, Uni- or bilateral, Conductive, sensorineural or mixed, Mild to profound, Presence of a chronic tinnitus.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0507332
Registration Date
October 03, 2022
Retention Due Date
October 02, 2025
Product Owner
Short Name
Sovona AG
Address
Laubisrutistrasse 28, 8712 Stafa, SWITZERLAND
Registrant
Address
8 KALLANG AVENUE, APERIA, #13-08, SINGAPORE 339509
Importer
Address
21 MEDIA CIRCLE, INFINITE STUDIOS, #07-01/04, SINGAPORE 138562
Model Information
Model Name(s)
Phonak Target Phonak Virto P90-Titanium Phonak Virto P90-10 NW O Phonak Virto P90-312 NW O Phonak Virto P70-Titanium Phonak Virto P70-10 NW O Phonak Virto P70-312 NW O Phonak Virto P50-10 NW O Phonak Virto P50-312 NW O Phonak Virto P30-10 NW O Phonak Virto P30-312 NW O
Model Identifier(s)
058-0125-073 063-0001-01 063-0002-01 063-0003-01 063-0005-01 063-0006-01 063-0007-01 063-0508-01 063-0509-01 063-0511-01 063-0512-01