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ID
Source
Brief title
Health condition
- Severe-to-profound sensorineural hearing loss
- Cochlear implantation
- Electrode tip foldover
- Residual hearing loss
Sponsors and support
Intervention
Outcome measures
Primary outcome
Occurrence of intraoperative tip fold-over and evaluation of the intracochlear position of electrode contacts (ST or SV) per participant
Secondary outcome
1. Residual hearing thresholds and speech perception in relation to intracochlear location of electrode contacts per participant.
2. Compare audiometric outcome and translocation rate between surgical techniques (RW vs CS).
Background summary
Rationale:
Due to the continuingly expanding indications for cochlear implantation, preservation of residual hearing has become an important objective. Evidence suggests that overall outcome and hearing preservation are influenced directly by occurrence of insertional trauma (i.e. lateral wall/modiolar trauma, translocation from scala tympani to scala vestibuli, tip fold-over) during surgery. Therefore there is an increasing interest in hypotraumatic insertion techniques as well as hypotraumatic electrode arrays. The Slim Modiolar Electrode (SME) was developed in 2016 to be atraumatic, more flexible and thinner than previous generations of precurved electrode arrays by the manufacturer. Heutink et al. confirmed the potential for the SME to preserve residual hearing once the electrode was positioned entirely in the scala tympani (ST). However, they observed cochleostomy associated translocation to the scala vestibuli (SV) in more than one third of the participants, resulting in significant hearing loss. They therefore advise to use the round window (RW) or extended round window ((e)RW) approach when using the SME.
Objective:
To evaluate the intracochlear position of the Slim Modiolar Electrode array when inserting using the (e)RW approach.
Study design:
Prospective observational study
Study population:
The first 23 patients selected for implantation with the Slim Modiolar Electrode (CI532/CI632) using the (extended) round window approach at our center willing to participate.
Follow-up:
1 year.
Primary outcome measure:
Occurrence of intraoperative tip fold-over and evaluation of the intracochlear position of electrode contacts (ST or SV) per participant.
Secondary outcome measures:
Residual hearing thresholds and speech perception in relation to intracochlear location of electrode contacts per participant.
Study objective
Previously published research by Heutink et al. performed in our center found cochleostomy associated translocations in over a third of the patients implanted with the Slim Modiolar Electrode. Therefore, we would like to evaluate the translocation rate in a similar group of patients implanted with the SME using the (extended) round window approach. We expect to find a lower rate of electrode translocation in patients using this surgical technique.
Study design
1. <6 months prior to surgery
2. 2 months
3. 1 year
Intervention
-
Inclusion criteria
Patients selected for cochlear implantation with the Slim Modiolar Electrode (Cochlear Ltd.) in the Radboudumc who are willing to participate and have signed informed consent
Exclusion criteria
1. Contraindications for CT-scanning
2. Patients with anatomical variations of the cochlea that may influence normal insertion (this is judged on the pre-operative CT-scan)
3. Children (< 18 years)
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8290 |
| Other | CMO Radboudumc : 2019-5821 |