ateralization ability of interaural time differences of bilaterally CI-supplied patients with FS4 versus non-FS stimulation strategy

Not Applicable

Recruiting

• Conditions: H83; Other diseases of inner ear

• Registration Number: DRKS00033448
• Lead Sponsor: niversitätsklinikum Freiburg Klinik für Hals-, Nasen- und OhrenheilkundeSektion Cochlear Implant

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

The following inclusion criteria apply to all BiCI patients:
•both ears
-average unaided hearing threshold 4PTA (four-frequency pure-tone average (0.5, 1, 2, and 4 kHz)):= 80 dB HL
-simultaneous bilateral implantation or maximum implantation interval of = 1.5 years for prelingually deafened BiCI patients or = 2 years for postlingually deafened BiCI patients
-Hearing experience with CI: = 3 years.

• for patients who are prelingually deaf and bilaterally fitted with a MED-EL CI, the following additional inclusion criteria apply:
-bilateral fitting with CI (prelingual: age of deafness <3 years)
-Age at implantation of the 2nd CI = 3 years
•both ears
-Implant: C40+, PULSAR, CONCERTO, SYNCHRONY or SYNCHRONY 2 same or different on both sides
-Use of the FS4 strategy since the initial fitting of the sound processors.

• for patients who are prelingually deaf and bilaterally fitted with a CI from Cochlear, who are participating in the pilot study (phase 1), the following additional inclusion criteria:
-bilateral fitting with CI (prelingual: age of deafness < 3 years)
•both ears
-Implant: CI24R, CI24RE, CI422, CI512, CI522, CI532, CI612, CI622, CI632 the same or different on both sides.

• For patients with postlingual deafness and bilateral CIs from MED-EL, the following additional inclusion criteria were applied:
-bilateral fitting with CI (postlingual: age of deafness > 6 years)
•both CI ears
-implant: C40+, PULSAR, CONCERTO, SYNCHRONY or SYNCHRONY 2 on both sides the same or different
-Use of the FS4 strategy since the initial fitting of the sound processors.

•For patients with postlingual deafness and bilateral CI from Cochlear participating in the pilot study (phase 1), the following additional inclusion criteria apply:
-bilateral fitting with CI (postlingual: age of deafness > 6 years)
•both ears
-implant: CI24R, CI24RE, CI422, CI512, CI522, CI532, CI612, CI622, CI632 on both sides the same or different.

•The following inclusion criteria apply to subjects with normal hearing:
•Both ears
-Hearing threshold at all frequencies: = 20 dB HL.

Exclusion Criteria

The following exclusion criteria apply to all BiCI patients and NH subjects:
-Cognitive impairment.

Study & Design

• Study Type: interventional
• Study Design: Not specified