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Feasibility of intra-operative cochlear health monitoring to predict hearing preservation in cochlear implant recipients.

Feasibility of intra-operative cochlear health monitoring to predict hearing preservation in cochlear implant recipients.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619000131156
Enrollment
127
Registered
2019-01-30
Start date
2015-02-20
Completion date
Unknown
Last updated
2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A significant proportion of cochlear implant recipients lose all residual, natural hearing immediately after the surgery. The aim of this trial is to test the use of electrocochleography measured during implantation to estimate cochlear health, to predict the preservation of residual hearing. Patients will be followed up for 12 months after surgery.

Interventions

The loss of all natural hearing can occur immediately after cochlear implantation. In this study, the electrical response of the cochlea to acoustic tones will be measured 14 times per second during cochlear implantation (Intra-operative electrocochleography). This response will be monitored for sudden reductions in cochlear output, suggesting a reduction in hearing function. The electrical response will be monitored for the duration of the implantation, typically 5-10 minutes for a total surgic

The loss of all natural hearing can occur immediately after cochlear implantation. In this study, the electrical response of the cochlea to acoustic tones will be measured 14 times per second during cochlear implantation (Intra-operative electrocochleography). This response will be monitored for sudden reductions in cochlear output, suggesting a reduction in hearing function. The electrical response will be monitored for the duration of the implantation, typically 5-10 minutes for a total surgical observation time of 3 hours. Audiometric hearing thresholds will be measure pre-operatively and 3-months post-surgery for sessions of 30 minutes each. Total observation time per patient is approximately 4 hours.

Sponsors

University of Melbourne
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
1 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Any child or adult capable of participating with an audiogram, in whom a clinical recommendation has been made to receive a cochlear implant. Receiving a slim-straight Cochlear CI522 electrode array.

Exclusion criteria

Deafness due to cochlear malformations, including ossification, confirmed by medical examination Pre-existing cochlear implantation Any medical or psychological conditions inappropriate for general anaesthesia or surgery Any condition contraindicating cochlear implantation under current surgical guidelines

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026