| Primary Device ID | 09321502078955 |
| NIH Device Record Key | ee9795b3-5caf-447a-8d51-c04df47f0b72 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Baha Smart App |
| Version Model Number | V 1.2 |
| Catalog Number | P1646035 |
| Company DUNS | 559784736 |
| Company Name | Cochlear Bone Anchored Solutions AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Manufacturing Date | true |
| 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 |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com | |
| Phone | +1(800)523-5798 |
| customer@cochlear.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09321502078955 [Primary] |
| LXB | Hearing aid, bone conduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-13 |
| Device Publish Date | 2025-06-05 |
| 09321502053006 | P1646035 |
| 09321502052993 | P1646054 |
| 09321502078962 | iOS version of the Baha Smart App |
| 09321502078955 | Android version of the Baha Smart App |