To examine whether compromised cochlear microphonic (CM) response during cochlear implant surgery results in poorer acoustic hearing preservation compared to preserved CM.
ID
Source
Brief title
Condition
- Hearing disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Deterioration in average low frequency post-operative hearing threshold levels
(HTLs) at 4-6 weeks post-surgery in the implanted ear for subjects with
compromised Cochear Microphonics (CM) compared to subjects with preserved CM
during surgery.
Secondary outcome
1. Deterioration in average low frequency post-operative HTLs at 3 months
post-activation in the implanted ear for subjects with compromised CM compared
to subjects with preserved CM during surgery.
2. Association of pre-operative high frequency HTLs with onset of CM response
during electrode array insertion.
3. Safety data in the form of adverse events where they occur.
Background summary
Significant advancements in implantable device technology and refinements to
surgical technique have led to progressive improvement in the ability to
preserve acoustic hearing after implantation. However, although hearing
preservation has been demonstrated with a range of devices (Adunka et al. 2004;
Gantz and Turner 2004; Gstoettner et al. 2009; Fraysse et al. 2006; Gantz et
al. 2009; Lesinski-Schiedat et al. 2011; Lenarz et al. 2013; Lenarz et al.
2009; Skarzynski et al. 2010; Roland et al. 2016), it is not yet possible to
guarantee for an individual candidate that acoustic hearing will be preserved.
Although the cause of post-operative hearing loss is likely multifactorial,
events that occur during surgery are likely to be of influence. In order to
understand the influence of such surgical factors, it is important to develop
monitoring and diagnostic tools for use in the clinical setting, and to
determine the specific intra-operative events that are associated with acoustic
hearing loss. Furthermore, if reliable intra-operative tools were developed it
may be possible to provide near real-time feedback to the surgeon as to change
in acoustic hearing status during electrode insertion, and for the surgeon to
modify or refine the surgical technique to minimize risk to loss of acoustic
hearing.
Study objective
To examine whether compromised cochlear microphonic (CM) response during
cochlear implant surgery results in poorer acoustic hearing preservation
compared to preserved CM.
Study design
Prospective, multi-center, observational (non-randomized) investigation.
Study burden and risks
Participation in the trial requires time investment (four visits of about one
hour each, which are part of the standard clinical procedure for cochlear
implantation) and effort to complete routine measurements. The experimental
Cochlear Response Telemetry measurements (electrocochleography) will be
performed intra-operative and either 4-6 weeks post-operative or 3 months
post-activation. It is anticipated that the additional time required to conduct
the intra-operative measurement will be 10-15 minutes. The post-operative
measurement will take approximately 30-60 minutes.
The risks associated with this investigational device are considered to be low.
There will be no benefit for the subject from participation in this research.
However, it is possible that the information obtained from this study will
assist in future to develop reliable tools to improve the cochlear implant
surgery.
1 University Avenue Macquarie University
Sydney NSW 2019
AU
1 University Avenue Macquarie University
Sydney NSW 2019
AU
Listed location countries
Age
Inclusion criteria
* Candidate for cochlear implantation according to local indications
* 18 years of age or older at the time of enrolment
* Pre-operative audiometric threshold in the implanted ear at 500 Hz of better
than or equal to 80 dB HL
* Willingness to participate in and to comply with all requirements of the
protocol
Exclusion criteria
* Prior cochlear implantation in the ear to be implanted
* Ossification or any other cochlear anomaly that might prevent complete
insertion of the electrode array
* Abnormal cochlear/nerve anatomy on pre-operative CT or MRI imaging (excluding
a mild Mondini malformation or Large Vestibular Aqueduct Syndrome)
* Deafness due to lesions of the acoustic nerve or central auditory pathway
* Diagnosis of auditory neuropathy
* Active middle-ear infection
* Additional handicaps that would prevent participation in evaluations
* Unrealistic expectations on the part of the subject, regarding the possible
benefits, risks and limitations that are inherent to the procedure and
investigational 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 |
|---|---|
| ClinicalTrials.gov | NCT03134989 |
| CCMO | NL61426.091.17 |