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Starkey STARKEY Genesis AI Hearing Aids (ITE, Digital) - HSA Registration DE0508810

Access comprehensive regulatory information for Starkey STARKEY Genesis AI Hearing Aids (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 DE0508810 and owned by Starkey Laboratories Inc.. The device was registered on January 04, 2024.

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
DE0508810
Starkey STARKEY Genesis AI Hearing Aids (ITE, Digital)
HSA Registration Number: DE0508810
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Product Description

An air conduction hearing aid is a wearable sound-amplifying device 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 Multi flex 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. The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Ear, Nose & Throat
Registration Information
Registration Number
DE0508810
Registration Date
January 04, 2024
Retention Due Date
January 03, 2026
Product Owner
Short Name
Starkey Laboratories Inc.
Address
6700 Washington Avenue S, 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)
STARKEY GENESIS AI 24 IIC NW STARKEY GENESIS AI 20 IIC NW STARKEY GENESIS AI 16 IIC NW STARKEY GENESIS AI 24 CIC NW STARKEY GENESIS AI 20 CIC NW STARKEY GENESIS AI 16 CIC NW STARKEY GENESIS AI 12 CIC NW Starkey Pro Fit
Model Identifier(s)
72021-SHT 72022-SHT 72023-SHT 72047-SHT 72048-SHT 72049-SHT 72050-SHT Pro Fit