Dataset Information

Evaluating cochlear insertion trauma and hearing preservation after cochlear implantation (CIPRES): a study protocol for a randomized single-blind controlled trial.

ABSTRACT:

Background

In order to preserve residual hearing in patients with sensorineural hearing loss (SNHL) who receive a cochlear implant (CI), insertion trauma to the delicate structures of the cochlea needs to be minimized. The surgical approach comprises the conventional mastoidectomy-posterior tympanotomy (MPT) to arrive at the middle ear, followed by either a cochleostomy (CO) or the round window (RW) approach. Both techniques have their benefits and disadvantages. Another important aspect in structure preservation is the design of the electrode array. Two different designs are used: a "straight" lateral wall lying electrode array (LW) or a "pre-curved" perimodiolar lying electrode array (PM). Interestingly, until now, the best surgical approach and design of the implant is uncertain. Our hypothesis is that there is a difference in hearing preservation outcomes between the four possible treatment options.

Methods

We designed a monocenter, multi-arm, randomized controlled trial to compare insertion trauma between four groups of patients, with each group having a unique combination of an electrode array type (LW or PM) and surgical approach (RW or CO). In total, 48 patients will be randomized into one of these four intervention groups. Our primary objective is the comparison of postoperative hearing preservation between these four groups. Secondly, we aim to assess structure preservation (i.e., scalar translocation, with basilar membrane disruption or tip fold-over of array) for each group. Thirdly, we will compare objective outcomes of hearing and structure preservation by way of electrocochleography (ECochG).

Discussion

Cochlear implantation by way of a cochleostomy or round window approach, using different electrode array types, is the standard medical care for patients with severe to profound bilateral sensorineural hearing loss, as it is a relatively simple and low-risk procedure that greatly benefits patients. However, loss of residual hearing remains a problem. This trial is the first randomized controlled trial that evaluates the effect of cochlear insertion trauma of several CI treatment options on hearing preservation.

Trial registration

Netherlands Trial Register (NTR) NL8586 . Registered on 4 May 2020. Retrospectively registered; 3/48 participants were included before registration.

SUBMITTER: Jwair S

PROVIDER: S-EPMC8656003 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Access to low-frequency acoustic information in cochlear implant patients leads to better speech understanding in noise. Electrocochleography (ECochG) can provide real-time feedback about the health of the cochlea during the insertion process with the potential to reduce insertion trauma. We describe our experiences of using this technique. Data from 47 adult subjects with measurable residual hearing and an Advanced Bionics (Valencia, CA) SlimJ (46) or MidScala (1) electrode array were analyzed. ECochGs were recorded intraoperatively via the implant. The surgeon adjusted the course of the electrode insertion based on drops in the ECochG. The final array position was assessed using postoperative imaging and pure tone thresholds were measured before and after surgery. Three different patterns of ECochG response amplitude were observed: Growth, Fluctuating and Total Loss. Subjects in the growth group showed the smallest postoperative hearing loss. However, the group with fluctuating amplitudes showed no meaningful correlation between the ECochG responses and the postoperative hearing loss, indicating that amplitude alone is insufficient for detecting damage. Considering the phase of the signal additionally to the amplitude and reclassifying the data by both the phase and amplitude of the response into three groups Type I-Type III produced statistically significant correlations between postoperative hearing loss and the grouping based on amplitude and phase respectively. We showed significantly better hearing preservation for Type I (no drop in amplitude) and Type II (drop with a concurrent phase shift), while Type III (drop without concurrent phase shift) had more surgery induced hearing loss. ECochG potentials measured through the implant could provide valuable feedback during the electrode insertion. Both the amplitude and phase of the ECochG response are important to consider. More data needs to be evaluated to better understand the impact of the different signal components to design an automated system to alert the surgeon ahead of damaging the cochlea.

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