mild to severe deafness
Conditions
Interventions
None listed
Sponsors
Advanced Bionics Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: •18 years of age or older •Definite Postlingual onset of severe-to-profound hearing loss as documented by completing main stream primary education •Preferably, aided mono- or bisyllabic word score of >= 15 % at 65 dB SPL in quiet in the ear to be implanted •Local language proficiency •Bilateral, sensorineural hearing loss of a mild to moderate degree in the low frequencies and a severe or a greater degree of hearing loss in the mid-to-high frequencies, defined as pure-tone thresholds (PT): - PT = 70 dB HL at 2000, 4000, and 8000 Hz •Contralateral ear PTA ± 30 dB HL at 250, 500, 750 and 1000 Hz as compared to the ear to be implanted
Exclusion criteria
Exclusion criteria: •Previous inner or major middle ear surgery or active middle ear pathology. •Cochlear malformation or obstruction as confirmed by pre OP MRI (an MRI is required to exclude obstruction when history indicates a higher risk for obstructions) •Presence of additional disabilities that would prevent or interfere with participation in the required study procedures •Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures •Evidence of central auditory lesion or compromised auditory nerve •Concurrent participation in other study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pagina 4 CIP Primary Study Objectives To demonstrate that free field word recognition scores in quiet and noise with CI *ON* are significantly better than the best aided pre-implant scores in the ear to be implanted (contralateral ear plugged) after 12 months of implant use. Primary Endpoint CI aided free field word recognition scores in quiet and noise after 12 months of implant use are significantly better than the best aided pre-implant baseline scores in the to be implanted ear (contralateral ear plugged). Primary Evaluation To demonstrate that word recognition scores in the implanted ear are significantly higher than scores at baseline with conventional amplification in the to be implanted ear. The null and alternate hypotheses to be tested are: H0: mu 0 where mu is the mean of the difference for words in quiet. Primary PMCF objective All adverse events will be tracked and reported after being adjudicated by a Data Safety Monitoring Board (DSMB) to evaluate whether there are adverse events related to the HiResolution system to be. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional Interest Evaluate the ability to preserve functional residual hearing after implantation with the HiFocus MS electrodes in adults with mild -to-moderate low-frequency hearing loss during the first 12 months of CI use. Additional Evaluation Classification of the preservation of residual hearing based on the unaided acoustic hearing thresholds measured at 1, 3, 6 and 12 months (under earphones) in the implanted ear as compared to the unaided pre-implant thresholds in the same ear for audiometric frequencies 125, 250, 500, 750 and 1000 Hz. Threshold changes from baseline will be calculated for each frequency separately and for a low-frequency pure-tone average (LF-PTA = average of 125, 250, 500 and 750 Hz). Individual-frequencies and LF-PTA results will be classified as follows: • Near complete preservation of hearing: threshold shift 50 Results to be divide between pure round window and insertion after extended round window/cochleostomy. Further initiatives • Full analysis at 3, 6 and 12 months follow up after device activation. • LF-PTA results to be divide between insertion via pure round window , extended round window or cochleostomy. • To demonstrate that aided sentence-in-quiet and noise scores in the implanted ear are significantly higher than aided scores at baseline with best aided conventional amplification in the to be implanted ear. • To evaluate acoustic only residual hearing during the first 12 months of implant use • Evaluate effect of the surgical procedure on residual hearing • Health Utilities Index 3 questionnaire at baseline and 3 months post activation | — |
Countries
Netherlands
Outcome results
None listed