OtoPad

GUDID 08059300420010

OtoPad is a software based audiometer used by a practitioner to test the hearing of a patient.

AMPLIFON SPA

Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Pure-tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08059300420010 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by AMPLIFON SPA

• 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