Status Telemetry for Cochlear Implantations (PATHOS)

I

Insel Gruppe AG, University Hospital Bern

Status

Enrolling

Conditions

Sensorineural Hearing Loss

Treatments

Device: STOP
Device: MAESTRO

Study type

Observational

Funder types

Other

Identifiers

NCT06223724
PATHOS

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

Cochlear implant electrode insertion depth estimation
Description:
Electrode insertion depth estimation using impedance telemetry data measured during cochlear implantation and at three regular follow-up visits
Treatment:
Device: MAESTRO
Device: STOP

Trial contacts and locations

1

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Central trial contact

Stephan Schraivogel, MSc; Wilhelm Wimmer, Prof.

Data sourced from clinicaltrials.gov

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