Insera S1-R 063-6392-01

GUDID 07613389812190

Sonova AG

Air-conduction hearing aid, in-the-ear

• Primary Device ID: 07613389812190
• NIH Device Record Key: 74ea1386-9a18-4f13-8a71-a9822bc3e5b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insera S1-R
• Version Model Number: N/A
• Catalog Number: 063-6392-01
• Company DUNS: 480662550
• Company Name: Sonova AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com
• Phone: +41589280101
• Email: info@sonova.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613389812190 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction With Wireless Technology, Prescription

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: 2025-12-29
• Device Publish Date: 2025-12-19

Devices Manufactured by Sonova AG

• 07613389837810 - TrueFit 5.9 USB: 2026-01-07
• 07613389837827 - Unitron TrueFit 5.9: 2026-01-07
• 07613389837841 - Aura:fit AudioNova 5.9: 2026-01-07
• 07613389837858 - Aura:fit Relate 5.9: 2026-01-07
• 07613389812190 - Insera S1-R: 2025-12-29
• 07613389812190 - Insera S1-R: 2025-12-29
• 07613389812206 - Insera S3-R: 2025-12-29
• 07613389813814 - Insera S5-R: 2025-12-29
• 07613389813821 - Insera S7-R: 2025-12-29