Signia 21011146

GUDID 05714880148688

Signia INSIO 7AX C&G Hearing Aid

SIVANTOS, INC.

Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear Air-conduction hearing aid, in-the-ear

• Primary Device ID: 05714880148688
• NIH Device Record Key: 4bfe65b5-8b06-4687-99d7-9733097db837
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signia
• Version Model Number: INSIO 7AX C&G
• Catalog Number: 21011146
• Company DUNS: 157412271
• Company Name: SIVANTOS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com
• Phone: 17325626600
• Email: consumerrelations@sivantos.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714880148688 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air Conduction With Wireless Technology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-07
• Device Publish Date: 2022-08-30

On-Brand Devices [Signia]

• 04056839073537: Signia HA MOTION 13P 7NX HC4 Hearing Aid
• 04056839073520: Signia HA MOTION 13P 5NX HC4 Hearing Aid
• 04056839073513: Signia HA MOTION 13P 3NX HC4 Hearing Aid
• 04056839070802: Signia S_ITE SILK 7NX L BLK TBLU Hearing Aid
• 04056839070796: Signia S_ITE SILK 7NX R BLK TRD Hearing Aid
• 04056839070789: Signia S_ITE SILK 5NX R BLK TRD Hearing Aid
• 04056839070772: Signia S_ITE SILK 5NX L BLK TBLU Hearing Aid
• 04056839070765: Signia S_ITE SILK 3NX L BLK TBLU Hearing Aid
• 04056839070758: Signia S_ITE SILK 3NX R BLK TRD Hearing Aid
• 04056839070741: Signia S_ITE SILK SDEMO DNX L BLK TBLU Hearing Aid
• 04056839070734: Signia S_ITE SILK SDEMO DNX R BLK TRD Hearing Aid
• 04056839070727: Signia S_ITE CROS SILK NX L BLK TBLU Hearing Aid
• 04056839070710: Signia S_ITE CROS SILK NX R BLK TRD Hearing Aid
• 04056839070703: Signia S_ITE SILK 7NX R MOC Hearing Aid
• 04056839070697: Signia S_ITE SILK 5NX R MOC TRD Hearing Aid
• 04056839070680: Signia S_ITE SILK 5NX L MOC TBLU Hearing Aid
• 04056839070673: Signia S_ITE SILK 3NX L MOC TBLU Hearing Aid
• 04056839070666: Signia S_ITE SILK 3NX R MOC TRD Hearing Aid
• 04056839070659: Signia S_ITE CROS SILK NX R MOC TRD Hearing Aid
• 04056839070642: Signia S_ITE CROS SILK NX L MOC TBLU Hearing Aid
• 04056839068526: Signia HA MOTION 13 5NX / T SLV Hearing Aid
• 04056839068519: Signia HA MOTION 13 5NX / T SB Hearing Aid
• 04056839068502: Signia HA MOTION 13 5NX / T PRL Hearing Aid
• 04056839068496: Signia HA MOTION 13 5NX / T GR Hearing Aid
• 04056839068489: Signia HA MOTION 13 5NX / T GNT Hearing Aid
• 04056839068472: Signia HA MOTION 13 5NX / T GB Hearing Aid
• 04056839068465: Signia HA MOTION 13 5NX / T DKC Hearing Aid
• 04056839068458: Signia HA MOTION 13 5NX / T DGT Hearing Aid
• 04056839068441: Signia HA MOTION 13 5NX / T DBR Hearing Aid
• 04056839068434: Signia HA MOTION 13 5NX / T BLK Hearing Aid
• 04056839068427: Signia HA MOTION 13 5NX / T BG Hearing Aid
• 04056839068410: Signia HA MOTION 13 3NX / T SLV Hearing Aid
• 04056839068403: Signia HA MOTION 13 3NX / T SB Hearing Aid
• 04056839068397: Signia HA MOTION 13 3NX / T PRL Hearing Aid
• 04056839068380: Signia HA MOTION 13 3NX / T GR Hearing Aid
• 04056839068373: Signia HA MOTION 13 3NX / T GNT Hearing Aid
• 04056839068366: Signia HA MOTION 13 3NX / T GB Hearing Aid
• 04056839068359: Signia HA MOTION 13 3NX / T DKC Hearing Aid
• 04056839068342: Signia HA MOTION 13 3NX / T DGT Hearing Aid
• 04056839068335: Signia HA MOTION 13 3NX / T DBR Hearing Aid
• 04056839068328: Signia HA MOTION 13 3NX / T Hearing Aid
• 04056839068311: Signia HA MOTION 13 3NX / T BG Hearing Aid
• 04056839068304: Signia HA MOTION 13 7NX / T SLV Hearing Aid
• 04056839068298: Signia HA MOTION 13 7NX / T SB Hearing Aid
• 04056839068281: Signia HA MOTION 13 7NX / T PRL Hearing Aid
• 04056839068274: Signia HA MOTION 13 7NX / T GR Hearing Aid
• 04056839068267: Signia HA MOTION 13 7NX / T GNT Hearing Aid
• 04056839068250: Signia HA MOTION 13 7NX / T Hearing Aid
• 04056839068243: Signia HA MOTION 13 7NX / T DKC Hearing Aid
• 04056839068236: Signia HA MOTION 13 7NX / T Hearing Aid