FDA.report

Signia

Primary DI
04063006010646
Brand
Signia
Company
Ws Audiology Usa, Inc.
Model
Silk X sDemoL
Catalog number
10970282
Device description
Silk X sDemoL Black
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OSMHearing Aid, Air Conduction With Wireless Technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04063006010646PrimaryGS10

GMDN Terms

TermDefinition
Air-conduction hearing aid, receiver-in-canalA battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.

Sterilization Methods

Method

Contacts

PhoneEmail
17325626600consumerrelations@sivantos.com

Regulatory Flags

DUNS number
157412271
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05714880221565RextonReach iX-CIC Li 60210351942026-01-24
05714880221572RextonReach iX-CIC Li 60210351962026-01-24
05714880221589RextonReach iX-CIC Li 60210351972026-01-24
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05714880223491RextonReach iX-CIC Li 30210353072026-01-24
05714880223507RextonReach iX-CIC Li 30210353092026-01-24
05714880223712RextonReach iX-CIC Li 20210353182026-01-24
05714880223729RextonReach iX-CIC Li 20210353192026-01-24
05714880223736RextonReach iX-CIC Li 20210353202026-01-24
05714880223743RextonReach iX-CIC Li 20210353212026-01-24
05714880275407RextonReach CROS R-Li T BC210473582026-01-24
05714880275438RextonReach CROS R-Li T BC210473552026-01-24
05714880275445RextonReach CROS R-Li T BC210473542026-01-24
05714880275469RextonReach CROS R-Li T BC210473522026-01-24
05714880289640TRUHEARINGTH Advanced 7 SP BTE LI210525382026-01-23
05714880289657TRUHEARINGTH Premium 7 SP BTE LI210525372026-01-23
05714880289664TRUHEARINGTH Advanced 7 SP BTE LI210525362026-01-23

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07613389755763Phonak Audéo E50-RSonova AGOSM2026-03-17
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07613389761917Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761924Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761931Phonak Audéo E30-RSonova AGOSM2026-03-17
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07613389761979Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761986Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761993Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762006Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762013Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762020Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762037Phonak Audéo E50-RSonova AGOSM2026-03-17
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07613389762099Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762105Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762143Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762150Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762167Phonak Audéo E70-R Sonova AGOSM2026-03-17