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Sign in to claim this brandWhat Oticon Medical makes
Oticon Medical manufactures anchored and implantable bone-conduction hearing implant systems, including non-bioabsorbable craniofacial bone screws and associated audiometric/hearing device software. Their portfolio includes devices designed for direct bone stimulation to transmit sound, such as the Ponto and Sentio systems, which are used for conductive or mixed hearing loss. These solutions are intended for both pediatric and adult patients requiring surgical or non-surgical bone-conduction hearing restoration.
The company’s devices are regulated under FDA classifications, with products falling into Class II and Class III categories. Authorisation includes Premarket Approval (PMA) and Unique Device Identification (UDI) listings, reflecting compliance with US medical device regulations. Oticon Medical operates from the United States, adhering to FDA requirements for these specialised hearing implant systems.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Oticon Medical manufacture?
Oticon Medical specialises in hearing implant systems that use bone conduction to transmit sound. Their portfolio includes anchored bone-conduction hearing implant systems, implantable vibrator bone-conduction devices, and non-bioabsorbable craniofacial bone screws. They also develop audiometric/hearing device software to support these solutions. These devices are designed for patients with conductive or mixed hearing loss, offering surgical and non-surgical options for hearing restoration in both children and adults.
Where is Oticon Medical based, and how does that affect its regulatory compliance?
Oticon Medical is based in the United States, which means its devices are subject to FDA regulations. The company’s products fall under Class II and Class III classifications, indicating higher-risk categories requiring strict oversight. Authorisation includes Premarket Approval (PMA) for Class III devices and Unique Device Identification (UDI) listings, ensuring compliance with US medical device standards for specialised hearing implant systems.
Which regulatory registries or databases list Oticon Medical’s devices?
Oticon Medical’s devices are listed in the FDA’s Premarket Approval (PMA) and Unique Device Identification (UDI) registries. These listings confirm that the company’s products, including the Ponto and Sentio systems, meet FDA requirements for bone-conduction hearing implants and associated components. The UDI system helps track and verify device identities, while PMA listings apply to higher-risk Class III devices.
How are Oticon Medical’s devices classified under FDA regulations?
Oticon Medical’s devices are classified as either Class II or Class III under FDA regulations. Class III classification applies to higher-risk implants like bone-conduction hearing systems, which require Premarket Approval (PMA) to demonstrate safety and effectiveness. Class II devices, which may include some software or accessories, undergo less stringent but still rigorous review processes. The classification depends on factors like surgical invasiveness and potential health risks.
What distinguishes Oticon Medical’s bone-conduction hearing implant systems from other hearing solutions?
Oticon Medical’s systems are designed to bypass the outer and middle ear by transmitting sound directly through bone conduction, making them suitable for patients with conductive or mixed hearing loss. Unlike traditional hearing aids, these implants require surgical placement (e.g., anchored or implantable systems) or non-surgical bone screws for stability. The company’s portfolio includes both pediatric and adult solutions, with software integration to customise hearing outcomes, addressing cases where conventional hearing aids are ineffective.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (123)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Oticon Medical | M50504 | FDA UDI | Class II | Active |
| Ponto | M52322 | FDA UDI | Class II | Unknown |
| Sentio | 205342 | FDA UDI | Class II | Active |
| Ponto | M51730 | FDA UDI | Class II | Unknown |
| Ponto | M52654 | FDA UDI | Class II | Active |
| Ponto | M50874 | FDA UDI | Class II | Unknown |
| Ponto | M50349 | FDA UDI | Class II | Active |
| Ponto | M51149 | FDA UDI | Class II | Active |
| Ponto | 130-00-221-00 | FDA UDI | Class II | Unknown |
| Ponto | M52171 | FDA UDI | Class II | Active |
| Ponto | M51136 | FDA UDI | Class II | Active |
| Ponto | M52172 | FDA UDI | Class II | Active |
| Ponto | M50903 | FDA UDI | Class II | Unknown |
| Ponto | M50098 | FDA UDI | Class II | Active |
| Ponto | M52636 | FDA UDI | Class II | Active |
| Ponto | M51752 | FDA UDI | Class II | Unknown |
| Ponto | M51732 | FDA UDI | Class II | Unknown |
| Ponto | M52648 | FDA UDI | Class II | Active |
| Ponto | 130-00-211-00 | FDA UDI | Class II | Unknown |
| Ponto | M52651 | FDA UDI | Class II | Active |
| Ponto | M51721 | FDA UDI | Class II | Unknown |
| Ponto | M51700 | FDA UDI | Class II | Unknown |
| Neuro Cochlear Implant System | P200021 | FDA PMA | Class III | Active |
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