FDA UDI Not in Commercial Distribution 🇺🇸 United States

HEAR.COM

DI: 04056839098448 · Model: horizon 1X RIC-S · Ws Audiology Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
HEAR.COM
Primary DI
04056839098448
Version / Model
horizon 1X RIC-S
Catalog Number
10997393
Company Name
Ws Audiology Usa, Inc.
Labeler DUNS
157412271
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-03-17
Public Version
2
Public Version Date
2026-01-07
Public Version Status
Update
Public Device Record Key
36541b02-ba27-46fe-bc8a-6b88a51212e0
Distribution End Date
2025-11-01

Device Description

HA HC HORIZON 1X RIC-S SNW SNWG

Device Characteristics

Single Use
No
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
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
OSM Hearing Aid, Air Conduction With Wireless Technology

GMDN Terms

Code Name
47169 Air-conduction hearing aid, receiver-in-canal

Identifiers

Type ID
Primary 04056839098448

Customer Contacts

Phone
17325626600