MedDRA - bilateral sensorineural hearing loss
Conditions
Interventions
Group 1: Phoenix Research System comprising of the CI1032 cochlear implant , the CP1000 Smart sound processor with investigational firmware in both monopolar (MP) and focused multipolar stimulation (F
Sponsors
Cochlear Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Individuals aged 18 years and older who have clinically established post-linguistic bilateral sensorineural hearing loss, and who have compromised functional hearing with hearing aids or would receive no benefit with hearing aids and who meet candidacy criteria for cochlear implantation. 2) Fluent speaker in the language used to assess clinical performance as judged by the investigator. 3) Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1) Previous or existing cochlear-implant recipient. 2) Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to two years of age as reported by the subject. 3) Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL in the better ear. 4) Adults with functional acoustic hearing in the ear to be implanted who desire to use an acoustic component post-operatively. 5) Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array. 6) Diagnosis of auditory neuropathy. 7) Deafness due to lesions of the acoustic nerve or central auditory pathway. 8) Medical or psychological conditions that would contraindicate undergoing surgery. 9) Women who are pregnant. 10) Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device. 11) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator 12) Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 13) Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 14) Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phoneme discrimination in noise (Language Independent Test - LIT) and spectral resolution test (Quick Spectral Modulation Detection - QSMD) for MP ACE condition at 5.5 months post-activation Sentence in noise performance (S0N0) for MP SPACE, FMS SPACE and FMS Modified programs at 7 months, 8 months, and 9 months post-activation | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent correct words in quiet performance (S0) at 65 dB SPL and 50 dB SPL at 7 months, 8 months, and 9 months post-activation Proportion of music quality preference ratings at 9 months and 9.5 months post-activation for pairwise comparisons of musical excerpts with the 3rd fitted NSC strategy and MP ACE Short form of the Speech, Spatial and Qualities of Hearing Scale (SSQ12) ratings collected at 7 months, 8 months and 9 months post-activation for: • MP SPACE • FMS SPACE • FMS Modified • Sentence in noise performance (S0N0) at 6 months and 9.5 months post-activation for MP ACE and at 7 months, 8 months and 9 months post-activation for NSC programs • Word recognition in quiet at 65 dB SPL at 6 months and 9.5 months post-activation for MP ACE and at 7 months, 8 months and 9 months post-activation for NSC programs • SSQ12 ratings collected remotely during take-home periods with each NSC program and MP ACE 6 months post-implantation words in quiet performance (S0) at 65 dB SPL 6 months post-implantation subjective ratings of quality and speech intelligibility (SSQ12) Adverse events and device deficiencies reported for the duration of the clinical investigation | — |
Countries
Germany, Italy, Netherlands
Contacts
Public ContactLieselot Houspie
Cochlear Benelux NV
Outcome results
None listed