| Primary Device ID | 08059300420010 |
| NIH Device Record Key | 23d2bdea-5dfe-4cdd-b9e0-5bf3cfeb6d1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OtoPad |
| Version Model Number | 2.0 |
| Company DUNS | 428013775 |
| Company Name | AMPLIFON SPA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08059300420010 [Primary] |
| EWO | Audiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-04 |
| Device Publish Date | 2023-06-26 |
| 08059606110356 - Miracle-Ear App | 2025-07-04 Hearing device app |
| 08059300420010 - OtoPad | 2023-07-04OtoPad is a software based audiometer used by a practitioner to test the hearing of a patient. |
| 08059300420010 - OtoPad | 2023-07-04 OtoPad is a software based audiometer used by a practitioner to test the hearing of a patient. |
| 00860001471724 - Miracle Ear App | 2021-04-08 |
| 00860001471731 - Miracle Ear App | 2021-04-08 |
| 00860001471700 - Miracle-Ear App | 2020-02-28 App IOS 2.0.1. This database entry also covers the following minor software updates: v2.0.2: (01)00860001471700(11)190807(10)202 |
| 00860001471717 - Miracle-Ear App | 2020-02-28 App Android 2.0.1. This database entry also covers the following minor software updates: v2.0.2: (01)00860001471717(11)190807(1 |