#SFHS2616495AFrance Adds Cochlear OSIA 3 Hearing Implant System to Reimbursement List
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This measure adds Cochlear France’s OSIA 3 active transcutaneous bone-conduction hearing implant system to France’s reimbursable medical products list. It covers the implant kit and related audio processor for adults with certain mixed, conductive, or severe single-sided sensorineural hearing loss, where a percutaneous bone-anchored system is not suitable. Hospitals and specialist hearing teams can use the reimbursement listing when prescribing and implanting OSIA 3, but only under defined clinical conditions. Care must be handled by a trained multidisciplinary team, including an ENT specialist and a hearing-aid professional, with pre-implant assessment, trial where possible, surgery, fitting, and follow-up.
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Key Changes
- Adds the Cochlear OSIA 3 implant kit to the reimbursable products list under active transcutaneous bone-conduction hearing implants.
- Adds the OSIA 3 audio processor to the reimbursable list for hearing implant processors and related equipment.
- Sets covered indications, prescribing conditions, team requirements, warranty terms, and reimbursement end date for the OSIA 3 implant kit.
Obligations
What this law requires
OSIA 3 may be prescribed and implanted for reimbursement only for adult patients with mixed or conductive hearing loss with bone-conduction pure-tone thresholds ≤55 dB, or at least severe unilateral sensorineural hearing loss, and with a local or general contraindication to a percutaneous bone-anchored system.
OSIA 3 must be prescribed and implanted by a multidisciplinary team that has received specific training for implantation and includes at least an ENT specialist and a hearing-aid professional.
Before implantation, the care team must perform a pre-implantation clinical and audiometric assessment of the patient.
Where possible, the care team must conduct a standardized prior trial with air-conduction and bone-conduction hearing prostheses for approximately three weeks to assess the benefit of available prosthetic options in daily-life conditions.
After the prior prosthesis trial, the care team must assess objective and subjective benefit using tonal and vocal audiometry in quiet and noise, quality-of-life questionnaire, and stereo-audiometry in relevant situations.