Miracle-Ear 21050304

GUDID 05714880285949

HA MEPOWER E 1 5W B-RUP DBR

Ws Audiology Usa, Inc.

Air-conduction hearing aid, behind-the-ear

• Primary Device ID: 05714880285949
• NIH Device Record Key: 389c006e-4d1c-49bc-871f-ba1b88f1984c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracle-Ear
• Version Model Number: MEPOWER E 1 5w B-RUP
• Catalog Number: 21050304
• Company DUNS: 157412271
• Company Name: Ws Audiology Usa, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714880285949 [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: 2025-11-28
• Device Publish Date: 2025-11-20

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• 05714880165814: Miracle-Ear HA MEMINI R 3 AX 312 SB Hearing Aid
• 05714880165807: Miracle-Ear HA MEMINI R 2 AX 312 SB Hearing Aid
• 05714880165791: Miracle-Ear HA MEMINI R 3 AX 312 PRL Hearing Aid
• 05714880165784: Miracle-Ear HA MEMINI R 2 AX 312 PRL Hearing Aid
• 05714880165777: Miracle-Ear HA MEMINI R 3 AX 312 GNT Hearing Aid
• 05714880165760: Miracle-Ear HA MEMINI R 2 AX 312 GNT Hearing Aid
• 05714880165753: Miracle-Ear HA MEMINI R 3 AX 312 DKC Hearing Aid
• 05714880165746: Miracle-Ear HA MEMINI R 2 AX 312 DKC Hearing Aid
• 05714880165739: Miracle-Ear HA MEMINI R 3 AX 312 DBR Hearing Aid
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• 05714880165715: Miracle-Ear HA MEMINI R 3 AX 312 BLK Hearing Aid
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• 05714880165555: Miracle-Ear HA MECONNECT R 5 AX 312 DBR Hearing Aid
• 05714880165548: Miracle-Ear HA MECONNECT R 5 AX 312 DKC Hearing Aid
• 05714880165531: Miracle-Ear HA MECONNECT R 5 AX 312 GNT Hearing Aid
• 05714880165524: Miracle-Ear HA MECONNECT R 5 AX 312 PRL Hearing Aid
• 05714880165517: Miracle-Ear HA MECONNECT R 5 AX 312 SB Hearing Aid
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• 05714880165487: Miracle-Ear HA MECONNECT R 4 AX 312 SB Hearing Aid
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• 05714880165463: Miracle-Ear HA MECONNECT R 4 AX 312 GNT Hearing Aid
• 05714880165456: Miracle-Ear HA MECONNECT R 4 AX 312 DKC Hearing Aid
• 05714880165449: Miracle-Ear HA MECONNECT R 4 AX 312 DBR Hearing Aid
• 05714880165432: Miracle-Ear HA MECONNECT R 4 AX 312 BLK Hearing Aid
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• 05714880165395: Miracle-Ear HA MEMINI R 3 AX 312 BG Hearing Aid
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• 05714880165357: Miracle-Ear SET MECROS R AX 312 BLK CROS device
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• 05714880165333: Miracle-Ear SET MECROS R AX 312 DKC CROS device
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