Esteem® Sound Processor

Basic Information

• Brand Name: Esteem® Sound Processor
• Primary DI: 00812282020207
• Version / Model: 2001
• Catalog Number: 902001-002
• Company Name: Envoy Medical Corporation
• Labeler DUNS: 939725313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 4
• Public Version Date: 2018-12-21
• Public Version Status: Update
• Public Device Record Key: 7f8f884f-e0a5-4d8f-b44b-d44df0e88a64

Device Description

Sound Processor Model 2001, IS-1 Connector Ports

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAF	Implant, Hearing, Active, Middle Ear, Totally Implanted	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58991	Fully-implantable middle ear implant system	An implanted assembly of sterile devices intended to compensate for impaired hearing by transmitting vibrations to the middle ear. It is powered by a battery that is recharged inductively, via an external device. It consists of a capsule, containing the battery and processor unit, and an attached microphone and transducer that are fully implanted. The microphone receives sound waves that are converted into electrical signals which drive the transducer to vibrate the middle ear bones, stimulating the auditory pathway. A middle ear implant (MEI) is typically used to treat sensorineural hearing loss (SNHL) or hearing impairment due to middle and/or outer ear obstructive pathologies.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812282020207	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P090018	000
P090018	011

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, Handle with Care
• Type: Storage Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius