Miracle-Ear 21015424

GUDID 05714880166095

MEENERGY IR 5 AX CosmicBlue RoseGold

Ws Audiology Usa, Inc.

Air-conduction hearing aid, receiver-in-canal

• Primary Device ID: 05714880166095
• NIH Device Record Key: d9d27dc9-a363-4b97-8907-9762848dc4b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Miracle-Ear
• Version Model Number: MEENERGY IR 5 AX
• Catalog Number: 21015424
• 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
• 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	05714880166095 [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: 2023-09-25
• Device Publish Date: 2023-09-15

On-Brand Devices [Miracle-Ear]

• 05714880181524: Miracle-Ear HA MEENERGY IR 2 AX BLK BLKG Hearing Aid
• 05714880177145: Miracle-Ear HA MEENERGY IR 2 AX SNW SNWG Hearing Aid
• 05714880177138: Miracle-Ear HA MEENERGY IR 2 AX BLK BLKG Hearing Aid
• 05714880165821: Miracle-Ear HA MEMINI R 2 AX 312 SLV Hearing Aid
• 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
• 05714880165722: Miracle-Ear HA MEMINI R 2 AX 312 DBR Hearing Aid
• 05714880165715: Miracle-Ear HA MEMINI R 3 AX 312 BLK Hearing Aid
• 05714880165579: Miracle-Ear HA MECONNECT R 5 AX 312 BG Hearing Aid
• 05714880165562: Miracle-Ear HA MECONNECT R 5 AX 312 BLK Hearing Aid
• 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
• 05714880165500: Miracle-Ear HA MECONNECT R 5 AX 312 SLV Hearing Aid
• 05714880165494: Miracle-Ear HA MECONNECT R 4 AX 312 SLV Hearing Aid
• 05714880165487: Miracle-Ear HA MECONNECT R 4 AX 312 SB Hearing Aid
• 05714880165470: Miracle-Ear HA MECONNECT R 4 AX 312 PRL Hearing Aid
• 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
• 05714880165425: Miracle-Ear HA MECONNECT R 4 AX 312 BG Hearing Aid
• 05714880165418: Miracle-Ear HA MEMINI R 3 AX 312 SLV Hearing Aid
• 05714880165401: Miracle-Ear HA MEMINI R 2 AX 312 BLK Hearing Aid
• 05714880165395: Miracle-Ear HA MEMINI R 3 AX 312 BG Hearing Aid
• 05714880165388: Miracle-Ear HA MEMINI R 2 AX 312 BG Hearing Aid
• 05714880165371: Miracle-Ear HA MECON-MINI R AX 312 DEMO GNT Hearing Aid
• 05714880165364: Miracle-Ear SET MECROS R AX 312 BG CROS device
• 05714880165357: Miracle-Ear SET MECROS R AX 312 BLK CROS device
• 05714880165340: Miracle-Ear SET MECROS R AX 312 DBR CROS device
• 05714880165333: Miracle-Ear SET MECROS R AX 312 DKC CROS device
• 05714880165326: Miracle-Ear SET MECROS R AX 312 GNT CROS device
• 05714880165319: Miracle-Ear SET MECROS R AX 312 PRL CROS device
• 05714880165302: Miracle-Ear SET MECROS R AX 312 SB CROS device
• 05714880165296: Miracle-Ear SET MECROS R AX 312 SLV CROS device
• 05714880166262: MEENERGY IR AX Demo Black Silver
• 05714880166255: MEENERGY IR 5 AX Black Silver
• 05714880166248: MEENERGY IR 3 AX Black Silver
• 05714880166217: MEENERGY IR 3 AX Black Black Gloss
• 05714880166200: MEENERGY IR 4 AX Black Black Gloss
• 05714880166194: MEENERGY IR 5 AX Black Black Gloss