Ponto Bone Anchored Hearing System MONO Surgery Kit
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203807 FDA 510(k)
- FDA Product Code
- MAH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3302 FDA 510(k)
- Regulation Number
- 874.3302 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ponto Bone Anchored Hearing System MONO Surgery Kit is a Bone Conduction, Implanted Hearing Aid designed for surgical implantation. It is intended for patients with conductive or mixed hearing loss, single-sided deafness, or unilateral/bilateral fitting needs, providing auditory rehabilitation through osseointegrated bone conduction.
This kit is supplied sterile and intended for single-use in surgical procedures, specifically the MONO technique for adults aged 18 and older with normal anatomy. It is classified as a Class II medical device under FDA regulations and authorized under the Medical Device Regulation (MDR). The kit includes components for minimally invasive implantation, adhering to Ear, Nose, and Throat (ENT) surgical standards.
Frequently asked questions
What patient populations is the Ponto Bone Anchored Hearing System MONO Surgery Kit designed for, and what age group is it approved for?
The Ponto Bone Anchored Hearing System MONO Surgery Kit is designed for adults aged 18 and older with normal anatomy who have conductive or mixed hearing loss, single-sided deafness, or unilateral/bilateral fitting needs. It is intended for auditory rehabilitation through osseointegrated bone conduction, specifically using the MONO surgical technique.
Is the Ponto Bone Anchored Hearing System MONO Surgery Kit sterile and single-use, and how is it intended to be used?
Yes, the kit is supplied sterile and intended for single-use in surgical procedures. It is designed for minimally invasive implantation in ENT surgeries, adhering to established surgical standards for bone-anchored hearing systems.
What regulatory pathways has the Ponto Bone Anchored Hearing System MONO Surgery Kit followed, and what classification does it hold?
The kit has been authorized under both the FDA’s 510(k) pathway (with a Special clearance type and classified as Substantially Equivalent) and the Medical Device Regulation (MDR). It is classified as a Class II medical device under FDA regulations.
What types of hearing loss conditions does this device address, and how does it work?
The Ponto Bone Anchored Hearing System MONO Surgery Kit addresses conductive or mixed hearing loss, single-sided deafness, and unilateral/bilateral fitting needs. It works by providing auditory rehabilitation through osseointegrated bone conduction, bypassing the outer and middle ear to transmit sound vibrations directly to the inner ear via the skull.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mono Surgery Kit - oticonmedical.com, Ponto Bone Anchored Hearing System, MONO Surgery Kit, PDF Ponto™ - Bone Anchored Hearing System System
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K203807 | Class II | Active |
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Manufacturer
- Manufacturer
- Oticon Medical AB
Sources (2)
- FDA 510(k) K203807 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026