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: Not specified

Target Recruitment: 23

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
<p>1. To evaluate whether neural health metrics predict performance outcomes with<br /><br>the MP ACE strategy post implantation<br /><br>2. To compare sentence in noise performance for three NSC implementations; MP<br /><br>SPACE, FMS SPACE and FMS Modified.</p><br>

Secondary Outcome Measures