The study is checking the safety and performance of the Sentio System, a hearing device, in kids aged 12-17. This system is used to help with hearing loss. Conductive hearing loss means there's a problem in the outer or middle ear, and sensorineural hearing loss means there's a problem in the inner ear. These children can be included if they have a certain level of hearing loss and have used hearing aids before. They should be able to follow study instructions too.
Some kids cannot join the study if they have certain medical conditions, like ongoing ear infections or allergies to materials in the device. The study also excludes those with health issues that make surgery unsafe or if they need devices that can't be removed.
- The study is for adolescents aged 12-17 with specific hearing loss conditions.
- Participants and their guardians must be willing to follow study procedures.
- Children with certain medical conditions or device use cannot join.