This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve adults with sensorineural hearing loss, a type of hearing loss caused by damage to the inner ear or auditory nerve (the nerve that carries sound signals from the ear to the brain). Participants will complete hearing tests and questionnaires to evaluate how well the system works and how it affects their daily life.
Individuals aged 18 years and older at time of consent.
Clinically established sensorineural hearing loss (SNHL) defined by a four frequency (500, 1000, 2000, 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥70 dB HL in the ear to be implanted.
Compromised functional hearing in the aided condition defined as ≤40% correct on a word recognition test in the ear to be implanted.
Clinically established SNHL defined by a four-frequency (500, 1000, 2000 & 4000 Hz) pure-tone average unaided threshold (PTA4) of ≥30 dB HL in the contralateral ear.
Prior cochlear implantation, in either ear, or medical plan for cochlear implantation during the clinical investigation, contralateral to the ear to be implanted.
Candidates with single-sided deafness as determined by the investigator.
Intra-axial (within-the-brain) lesions or deafness due to lesions of the acoustic nerve affecting the ear to be implanted.
Middle ear infection (including acute otitis media, chronic otitis media, suppurative otitis media, or serous drainage) in the ear to be implanted either at the time of surgery or within 3 months prior to enrolment.
Single group
Cochlear implant
DeviceTotally Implantable Cochlear Implant System
Speech recognition performance in quiet
Percent correct scores in word recognition score from pre-implantation to post-implantation.
Incidence of adverse events and device deficiencies
Frequency and severity of device and procedure-related adverse events, including device deficiencies.
Speech, Spatial and Qualities of Hearing questionnaire (SSQ-12)
Speech, Spatial, and Qualities of Hearing Scale global score (SSQ-12). Scores range from 0 to 10, where higher scores indicate greater ability (less hearing disability).
Speech recognition performance in noise
Percent correct sentence score from preimplantation to 6- and 12-months post-activation.
Speech recognition performance in quiet
Percent correct word recognition score in quiet from pre-implantation to post-implantation.
Cochlear Implant Quality of Life Profile (CIQOL-35)
Cochlear implant hearing related quality of life score (CIQOL-35). Scored for six health domains (communication, emotional, entertainment, environment, listening effort, and social) each scaled from 0 to 100, where a higher score indicates better health.
