FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Bose SoundControl Hearing Aid
DI: 00017817827416
·
Model: BMD0012
·
BOSE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Bose SoundControl Hearing Aid
- Primary DI
- 00017817827416
- Version / Model
- BMD0012
- Catalog Number
- 861812-0300
- Company Name
- BOSE CORPORATION
- Labeler DUNS
- 002579431
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-18
- Public Version
- 2
- Public Version Date
- 2022-10-18
- Public Version Status
- Update
- Public Device Record Key
- d872d9b6-f7e7-4418-ac3a-fbab6e162799
- Distribution End Date
- 2022-10-17
Device Description
A self-fitting wireless air conduction hearing aid.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QDD | Self-Fitting Air-Conduction Hearing Aid | Ear, Nose, Throat | 874.3325 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47169 | Air-conduction hearing aid, receiver-in-canal | A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It consists of a microphone and an amplifier in a case behind-the-ear (BTE) connected, via a wire, to a receiver (speaker) in the ear canal [receiver-in-canal (RIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00017817827416 | GS1 | ||||
| Package | 10017817827413 | GS1 | 6 | Not in Commercial Distribution | 2022-10-17 |
Customer Contacts
- Phone
- 1-877-230-5639
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 45 Degrees Celsius