This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: Neuro Cochlear Implant System
PMA Applicant: Oticon Medical
Address: 2720 Chemin de Saint Bernard, 06220 Vallauris, FRANCE
Approval Date: June 23, 2021
Approval Letter: Approval Order
What is it?
The Neuro Cochlear Implant System is intended to provide the user with hearing sensation through electrical stimulation of the hearing nerve (auditory nerve). The system consists of an external component, which sits behind the ear and internal components, including a receiver that is surgically placed under the skin of the patient and an electrode array that is inserted to the inner ear.
How does it work?
The internal component of the Neuro Cochlear Implant System is implanted by a surgeon. Sounds are picked up by the microphone of the external component and transformed into coded signals. The internal component translates these signals into electrical stimulation pulses which are sent to the inner ear (cochlea). These electrical pulses stimulate the auditory nerve and the brain recognizes these pulses as sound.
When is it used?
The Neuro Cochlear Implant System is used in patients 18 years and older, with hearing impairment (deafness) that is not improved by wearing hearing aids in both ears.
What will it accomplish?
The Neuro Cochlear Implant System provides useful hearing sensation to patients who are hard of hearing and are not helped by the use of traditional hearing aids in both ears.
When should it not be used?
The Neuro Cochlear Implant System should not be used in patients who have:
- A missing or under-developed cochlear or auditory nerve
- Hearing loss due to abnormal tissue growth (lesions) on the acoustic nerve or on the pathway that leads to the brain (central auditory pathway)
- A structure of the inner ear (cochlea) that doesn’t allow the device to be placed
- Current external or middle ear infections
- A hole (perforation) in the eardrum
- Any condition that prevents inner or middle ear surgery or anesthesia
- Any mental health condition that makes the patient experience a lack of self-control or may lead them to have unrealistic expectations about how the device will help them