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Status Telemetry for Cochlear Implantations

Recruiting
18 years of age
Both
Phase N/A

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Overview

Cochlear implants (CIs) are well-established neuroprosthesis used to restore hearing for patients with partial or complete deafness. However, the audiological outcomes of these implants can vary widely, and one reason for this is suboptimal electrode placement. The gold standard for measuring electrode positions is computed tomography (CT) scans, but they are expensive and expose patients to additional radiation, which is especially harmful for children.

This study investigates an alternative approach using impedance telemetry data to estimate electrode positions without exposing patients to radiation. For this purpose, an extended telemetry version of a CE-certified cochlear implant software is used. The advanced impedance telemetry software can measure impedance subcomponents with improved measurement resolution that could be used for more accurate estimation of electrode insertion depth using specially designed estimation software.

Ultimately, the investigators want to demonstrate the potential to improve audiological outcomes of cochlear implant recipients without exposing them to additional radiation.

Eligibility

Inclusion Criteria:

  • Informed Consent signed by the subject
  • Subjects scheduled for CI surgery according to clinical routine
  • Subjects who will receive a cochlear implant of the MED-EL portfolio (FLEX series arrays)
  • No radiological contraindications
  • Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria:

  • Lack of compliance with any inclusion criteria
  • Subjects incapable of giving informed consent
  • Age under 18 years
  • Pregnancy

Study details

Sensorineural Hearing Loss

NCT06223724

Insel Gruppe AG, University Hospital Bern

18 February 2024

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