Hearing and Structure Preservation Via ECochG

ConditionsHearing Loss, Sensorineural Severe-to-profound Hearing Loss

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAdvanced Bionics AG

About this trial

The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years of age or older

Within cochlear implant inclusion criteria by local regulations/guidelines at the time of implantation

Severe to profound hearing loss (average air conduction unaided hearing threshold of ≥ 70 dB HL for 500, 1000, 2000 and 4000 Hz) in the ear to be implanted

Air conduction unaided hearing threshold ≤ 70 dB HL at 500 Hz in the ear to be implanted

Disqualifiers

Abnormal cochlear anatomy (including ossification) as identified by pre-operative radiological evaluation in the ear to be implanted

Any pre-existing cochlear or middle ear pathology, such as otosclerosis, cholesteatoma, or previous middle ear surgery in the ear to be implanted

Any medical conditions that would increase the risk of local complications during cochlear implantation, such as autoimmune diseases or active local infections

Diagnosis of auditory spectrum neuropathy disorder

Trial design

Design model

Parallel

Treatments tested in this trial

ECochG monitored CI surgery incl. corrective action guide
Procedure/Surgery
Interventional surgery with surgeon having access to intra-operative ECochG monitoring feedback to deploy ECochG based corrective action guide
Routine CI surgery without ECochG monitoring
Procedure/Surgery
Routine CI surgery with access to ECochG monitoring by surgeon

Treatment groups

102 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

Hearing Preservation

Difference in dB (absolute) and % (relative) in low-frequency hearing preservation measured via air conduction pure tone audiometry

Time frame

From pre-operative to 6 months post-operative

Secondary outcomes

Structure Preservation

Difference in mm of structure preservation (distance from electrode contact to basilar membrane) via radiological assessment of the position of the electrode array

Time frame

1 month post-operative

Speech perception

Difference in speech perception scores in both quiet (%) and noise (dB SNR) using the International Matrix Test

Time frame

From pre-operative to 6 months post-operative