A prospective, multi-centre, repeated measures, traditional feasibility study investigating neural health correlates with outcomes and evaluating focused multipolar implementation in the Phoenix Research System for newly implanted adult cochlear implant recipients

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 51

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

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br><br>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 Outcome Measures

Name	Time	Method

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