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Starkey Audibel Via Rechargeable Hearing Aids (BTE, Wireless, Digital) - HSA Registration DE0506674

Access comprehensive regulatory information for Starkey Audibel Via Rechargeable Hearing Aids (BTE, Wireless, 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 DE0506674 and owned by Starkey Laboratories, Inc. The device was registered on February 23, 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
DE0506674
Starkey Audibel Via Rechargeable Hearing Aids (BTE, Wireless, Digital)
HSA Registration Number: DE0506674
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Product Description

An air conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing. Hearing aids are available in multiple gain/output levels appropriate to treat hearing losses ranging from mild to profound. The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0506674
Registration Date
February 23, 2022
Retention Due Date
February 22, 2026
Product Owner
Short Name
Starkey Laboratories, Inc
Address
6700 Washington Avenue South, Eden Prairie, Minnesota, 55344, UNITED STATES
Registrant
Address
85 PLAYFAIR ROAD, TONG YUAN INDUSTRIAL BUILDING, #04-02, SINGAPORE 368000
Importer
Address
151 LORONG CHUAN, NEW TECH PARK, #03-01B, SINGAPORE 556741 151 LORONG CHUAN, NEW TECH PARK, #03-01B, SINGAPORE 556741
Model Information
Model Name(s)
Thrive App Thrive App AUDIBEL VIA 2400 BTE R AUDIBEL VIA 2000 BTE R AUDIBEL VIA 1600 BTE R AUDIBEL VIA 1200 BTE R AUDIBEL VIA 1000 BTE R AUDIBEL VIA AI 2400 BTE R AUDIBEL VIA AI 2000 BTE R AUDIBEL VIA AI 1600 BTE R AUDIBEL VIA AI 1200 BTE R AUDIBEL VIA AI 1000 BTE R AUDIBEL VIA EDGE AI 2400 BTE R Inspire (Audible) Inspire (Audible)
Model Identifier(s)
842318130792 842318130808 842318176875 842318176905 842318176936 842318176981 842318177018 842318177049 842318177070 842318177100 842318177131 842318177162 842318177438 86448-010 86449-010