FDA.report

Miracle-Ear

Primary DI
05714880229301
Brand
Miracle-Ear
Company
Ws Audiology Usa, Inc.
Model
MECROS R R 5W
Catalog number
21030599
Device description
CCK MECROS R R 5W DBR
Published
2024-01-17
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

Contact Domains

Product Codes

CodeName
OSMHearing Aid, Air-Conduction With Wireless Technology, Prescription

Product Code Classifications

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05714880229301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05714880229301057148802293015714880229301

GMDN Terms

TermDefinition
Contralateral hearing unitA passive (i.e., non-powered) acoustic device intended to compensate for total hearing loss in one ear, by transmitting sound received by a microphone from the deaf ear to an active (i.e., powered) hearing aid worn on the hearing ear. This contralateral routing of sound (CROS) technology is designed to improve awareness of sounds (e.g., traffic, speech) emanating from all directions. The device typically consists of a microphone contained in a case worn behind-the-ear (BTE) with a connection cable. The cable both transmits the power from, and the signal to, the active hearing aid.

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05714880295054SIGNIAActive Mini 7IX210540642026-05-22
05714880295061SIGNIAActive Mini 5IX210543622026-05-22
05714880295078SIGNIAActive Mini 5IX210543672026-05-22
05714880295689SIGNIAActive Mini 7IX210540692026-05-22
05714880295764SIGNIAActive Mini 3IX210543632026-05-22
05714880295771SIGNIAActive Mini 3IX210543682026-05-22
05714880295825SIGNIAActive Mini 2IX210543642026-05-22
05714880295832SIGNIAActive Mini 2IX210543692026-05-22
05714880295887SIGNIAActive Mini 1IX210543652026-05-22
05714880295894SIGNIAActive Mini 1IX210543702026-05-22
05714880295948SIGNIAActive Mini sDEMO DIX210543662026-05-22
05714880295955SIGNIAActive Mini sDEMO DIX210543712026-05-22
05714880295962SIGNIAKit Active Mini sDEMO DIX210543762026-05-22
05714880295979SIGNIAKit Active Mini 7IX210540742026-05-22
05714880296006SIGNIAKit Active Mini 5IX210543722026-05-22
05714880296037SIGNIAKit Active Mini 3IX210543732026-05-22
05714880296068SIGNIAKit Active Mini 2IX210543742026-05-22
05714880296099SIGNIAKit Active Mini 1IX210543752026-05-22
05714880290356hear.comHORIZON RIC 1 G8210523302026-01-12
05714880221558RextonReach iX-CIC Li 60210351952026-01-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
05714880292077WidexWidex A/SOSM2026-05-22
05714880292084WidexWidex A/SOSM2026-05-22
05714880292091WidexWidex A/SOSM2026-05-22
05714880292107WidexWidex A/SOSM2026-05-22
05714880292114WidexWidex A/SOSM2026-05-22
05714880292121WidexWidex A/SOSM2026-05-22
05714880292138WidexWidex A/SOSM2026-05-22
05714880292145WidexWidex A/SOSM2026-05-22
05714880292152WidexWidex A/SOSM2026-05-22
05714880292169WidexWidex A/SOSM2026-05-22
05714880292176WidexWidex A/SOSM2026-05-22
05714880292183WidexWidex A/SOSM2026-05-22
05714880292190WidexWidex A/SOSM2026-05-22
05714880292206WidexWidex A/SOSM2026-05-22
05714880292213WidexWidex A/SOSM2026-05-22
05714880292220WidexWidex A/SOSM2026-05-22
05714880292237WidexWidex A/SOSM2026-05-22
05714880292244WidexWidex A/SOSM2026-05-22
05714880292251WidexWidex A/SOSM2026-05-22
05714880292268WidexWidex A/SOSM2026-05-22
05714880292275WidexWidex A/SOSM2026-05-22
05714880292282WidexWidex A/SOSM2026-05-22
05714880292299WidexWidex A/SOSM2026-05-22
05714880292305WidexWidex A/SOSM2026-05-22
05714880292312WidexWidex A/SOSM2026-05-22
05714880292329WidexWidex A/SOSM2026-05-22
05714880292336WidexWidex A/SOSM2026-05-22
05714880292343WidexWidex A/SOSM2026-05-22
05714880292350WidexWidex A/SOSM2026-05-22
05714880292367WidexWidex A/SOSM2026-05-22