This traditional feasibility study intends to inform a future pivotal trial in the following two ways. Firstly, it aims to evaluate the potential of neural health metrics triggered by FMS, to predict the implant recipient*s auditory performance -…
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To evaluate whether neural health metrics predict performance outcomes with
the MP ACE strategy post implantation
2. To compare sentence in noise performance for three NSC implementations; MP
SPACE, FMS SPACE and FMS Modified.
Secondary outcome
1. To compare words in quiet performance for three NSC implementations; MP
SPACE, FMS SPACE and FMS Modified.
2. To evaluate the benefit provided by NSC strategies for music appreciation
relative to the MP ACE strategy.
3. To compare subjective speech intelligibility, spatial and quality ratings
for MP SPACE, FMS SPACE and FMS Modified programs.
4. To compare speech perception performance outcomes for NSC strategies
relative to MP ACE.
5. To compare 6-month post implantation monosyllabic words in quiet scores with
MP ACE stimulation relative to State of the Art performance.
6. To compare 6-month post implantation subjective ratings of quality and
intelligibility with MP ACE stimulation relative to State of the Art
performance.
7. To evaluate safety data for the Phoenix Research System.
The study also has following exploratory objectives
• To characterize Electrode voltage Tomography (EVT) changes over time.
• To evaluate the relationship between changes in patient perception and
changes in objective speech perception metrics to inform minimum clinically
important differences for future studies.
Background summary
The Phoenix System implant is a next generation cochlear implant with advanced
stimulation capabilities compared to the standard cochlear implants. Phoenix
Research System, comprising the Phoenix cochlear implant paired with the
Nucleus 7 Smart sound processor, offers potential for improved hearing
performance using Focused Multipolar Stimulation (FMS) through novel hearing
paradigms. FMS narrows the spread of cochlear excitation from the active
electrode, which is expected to improve the spatial selectivity and spectral
resolution. FMS aims to enhance speech, environmental sound and music
perception and provide real-world clinical benefits over current stimulation
methods. There is potential to obtain further performance benefits over current
stimulation methods by combining FMS stimulation with SPACE (Spread
Precompensation Advanced Combination Encoder), a state-of the-art sound coding
strategy. The SPACE investigational strategy, like FMS, aims to reduce cochlear
spread of excitation, resulting in an increase spectral resolution.
Study objective
This traditional feasibility study intends to inform a future pivotal trial in
the following two ways. Firstly, it aims to evaluate the potential of neural
health metrics triggered by FMS, to predict the implant recipient*s auditory
performance - the ability to use basic auditory cues. Secondly, it aims to
inform future FMS program settings. The Novel Sound Coding (NSC) programs will
be compared to the baseline program across a range of metrics, including word
recognition in quiet, sentence recognition in noise, music appreciation and
subjective ratings of speech intelligibility and sound quality. The NSC
implementation that provides the best sentence in noise performance will inform
the strategy that may be evaluated in a future pivotal trial.
The study aims to inform the development of a new sound coding strategy using
the NSC. This study will investigate the potential benefits of the NSCs for
sentence in noise recognition in addition to other performance metrics,
including speech perception in quiet, music appreciation and subjective speech
intelligibility and quality ratings.
Study design
The study is a prospective, multi-country, multi-center, traditional
feasibility, single-blind, repeated measures investigation.
After surgical implantation and activation of the device, subjects will attend
scheduled study visits over a 9.5 month study period. At study visits,
subjects will undergo hearing assessments and safety assessments.
This duration will be extended with annual safety monitoring visits if the
CI1032 implant is not approved by end of Visit 8. The duration of the study
itself is approximately two years, but will take longer if the CI1032 implant
is not approved by Visit 8 of the last study participant.
Intervention
The CI1032 implant is the implanted component of a cochlear implant system and
is used in conjunction with an externally worn sound processor in order to
provide an auditory perception to patients. The implant system functions by
providing electrical stimulation to surviving neural elements in the cochlea,
bypassing the transduction mechanism normally provided by cochlear hair cells,
which have typically been impaired or are absent in such individuals.
The electrode array is inserted into the cochlea, either through a small
opening (cochleostomy) drilled by the surgeon or through an enlargement of the
round window. Electrodes in the lower (basal) region of the cochlea, closest to
the cochleostomy, stimulate auditory neural processes that perceive the high
frequency sounds while the more distal (apical) electrodes stimulate the apical
auditory neurons that perceive the lower frequencies. Further details on the
electrode insertion technique are provided in the CI1032 Physician*s Guide.
Study burden and risks
Potential benefits specifically associated with participation in the clinical
investigation include:
• Potential for improved hearing in areas such as speech perception, music
appreciation, and sound quality through access to and experience with a wider
range of stimulation paradigms than commercially available.
• Access to future product enhancements given that the research implant has
firmware that can be upgraded.
• Access to a smaller commercial sound processor when it becomes available
after completion of the study.
• Helping to find better treatments, therapies and/or diagnostic tests in the
area of hearing loss.
The potential clinical risks associated with the investigational device include
risks associated with receiving any cochlear implant. Risks specifically
associated with this investigation are as follows:
• The procedures conducted in this study include a post-operative CT scan,
which is not part of routine clinical care at all study sites. However, the
exposure is minimal, with an estimated radiation exposure to 0,18 milliSievert,
because only the inner ear will be exposed. The radiation dose to which an
average Dutch person is exposed per year is approximately 2.4 milliSievert
(mSv).
• Malfunction of worn or implanted electronic medical devices other than the
cochlear implant. The recipient will be advised to tell the study doctors and
research staff if they have an electronic medical device implanted such as a
pacemaker or a drug pump.
• During device programming there is a low risk that subjects may experience an
uncomfortably loud or painful sound due to a software or firmware bug or
clinician error. This risk is higher than with the predicate device implant,
given that several novel programs will be created for the subject. The risk is
mitigated by careful clinician training and software warnings.
• The CI1032 implant has built-in diagnostic tests to stop stimulation if any
errors occur in the device, resulting in a restart of the device. If this
happens the subject may experience a brief silence of up to 5 seconds until the
implant restarts. There is a low chance that the implant will not restart, and
in this situation the subject will need to attend the cochlear implant clinic
for reset.
• The study schedule requires several changes in listening programs over the
course of participation. Subjects may experience difficulty adjusting between
programs.
There are also limitations associated with using the Phoenix Research System as
listed below:
• Use of investigational stimulation strategies is restricted to participation
in the study. Subjects will be required to use standard strategies following
study completion, which may lead to disappointment if subjects preferred the
investigational strategy. While it is possible that such strategies may become
available following commercial approval, this is not guaranteed.
• Some accessories are not compatible with the investigational device,
including the Aqua+ system for waterproof hearing, certain retention
accessories and safety cords, telecoil, zinc air batteries, compact
rechargeable battery, Nucleus Smart App and streaming for Android, Roger FM
receiver, and Hybrid (electro-acoustic) hearing. Diagnostic features such as
microphone automatic diagnostic (MicAD) will not be available. Surgical
diagnostics will be limited to Auto-NRT and impedances. All of the above will
be available following commercial approval of the CI1032 implant.
• For a period of time between the end of the study and availability of the
commercial system, subjects will be limited to programming at the clinical site.
• Subjects are likely to experience a decrease in battery life for 3 months
during the study whilst using some of the NSC programs. Subjects will be
provided with extra rechargeable battery modules and battery charging units as
required.
Victoria Parade 174
East Melbourne VIC 3002
AU
Victoria Parade 174
East Melbourne VIC 3002
AU
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | DRKS00027817 |
| CCMO | NL80621.000.22 |