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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033448

Enrollment

Registered

2024-01-29

Start date

2024-04-03

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

H83

Interventions

Group 1: • Pre- and postlingually deaf children and adults with bilateral cochlear implants (BiCI) • Children and adults with normal hearing Time sequence and total duration of treatment. • For all s

Eligibility

Sex/Gender

All

Age

6 Years to No maximum

Inclusion criteria

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 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

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

Design outcomes

Primary

Measure	Time frame
Cochlear implants (CI) can provide deaf patients with the ability to hear. Unfortunately, one of the biggest challenges for patients with this hearing prosthesis is still directional hearing. Patients who became deaf at a young age or were born deaf are particularly affected. Apart from biological factors such as a lack of early development of the hearing system, this could also be due to limitations of current CI technology. In animal models, we were able to show that despite a lack of early hearing experience, bilateral CI users develop good directional hearing, given that the stimulation of their left and right ear is temporally modulated. This modulation provides important spatial cues, so-called interaural time differences. The technology available to the majority of human CI patients does not yet support this feature. The only exception is the CI stimulation strategy "FS4" developed by the company MED-EL, which could potentially provide these important directional cues permanently by temporally balancing the input from two CI ears. In this study, we want to investigate whether CI patients using this "FS4" strategy have better directional hearing than when using the conventional CI strategy, which does not support temporal modulation of bilateral CI input. In order to also be able to take into account the influence of hearing experience on directional hearing, both early deafened CI patients and late deafened CI patients are tested for their directional hearing. The groups are compared with each other and with the hearing performance of normal-hearing test subjects.	—

Measure

Time frame

Cochlear implants (CI) can provide deaf patients with the ability to hear. Unfortunately, one of the biggest challenges for patients with this hearing prosthesis is still directional hearing. Patients who became deaf at a young age or were born deaf are particularly affected. Apart from biological factors such as a lack of early development of the hearing system, this could also be due to limitations of current CI technology. In animal models, we were able to show that despite a lack of early hearing experience, bilateral CI users develop good directional hearing, given that the stimulation of their left and right ear is temporally modulated. This modulation provides important spatial cues, so-called interaural time differences. The technology available to the majority of human CI patients does not yet support this feature. The only exception is the CI stimulation strategy "FS4" developed by the company MED-EL, which could potentially provide these important directional cues permanently by temporally balancing the input from two CI ears. In this study, we want to investigate whether CI patients using this "FS4" strategy have better directional hearing than when using the conventional CI strategy, which does not support temporal modulation of bilateral CI input. In order to also be able to take into account the influence of hearing experience on directional hearing, both early deafened CI patients and late deafened CI patients are tested for their directional hearing. The groups are compared with each other and with the hearing performance of normal-hearing test subjects.

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Secondary

Measure	Time frame
• Differences in ITD sensitivity of prelingually deafened, early BiCI children with basal stimulation using the FS4 strategy compared to using a non-FS strategy • Differences in ITD sensitivity of prelingually deafened, early BiCI children using the FS4 strategy with apical stimulation compared to basal stimulation • Differences in ITD sensitivity of prelingually deafened children receiving early BiCI using a non-FS4 strategy with apical stimulation compared to basal stimulation • Differences in ITD sensitivity to apical stimulation between prelingually deafened children with early BiCI who use the FS4 stimulation strategy from fitting onwards and postlingually deafened BiCI patients with FS4 strategy •Differences in ITD sensitivity to apical stimulation between normal hearing and prelingually deafened children with early BiCI who use the FS4 stimulation strategy from the start of CI fitting	—

Measure

Time frame

• Differences in ITD sensitivity of prelingually deafened, early BiCI children with basal stimulation using the FS4 strategy compared to using a non-FS strategy • Differences in ITD sensitivity of prelingually deafened, early BiCI children using the FS4 strategy with apical stimulation compared to basal stimulation • Differences in ITD sensitivity of prelingually deafened children receiving early BiCI using a non-FS4 strategy with apical stimulation compared to basal stimulation • Differences in ITD sensitivity to apical stimulation between prelingually deafened children with early BiCI who use the FS4 stimulation strategy from fitting onwards and postlingually deafened BiCI patients with FS4 strategy •Differences in ITD sensitivity to apical stimulation between normal hearing and prelingually deafened children with early BiCI who use the FS4 stimulation strategy from the start of CI fitting

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Countries

Germany

Contacts

Public ContactNicole Roßkothen-Kuhl

UNIVERSITÄTSKLINIKUM FREIBURG Klinik für HNO-Heilkunde, Sektion experimentell-klinische Otologie, Neurobiologisches Forschungslabor

nicole.rosskothen-kuhl@uniklinik-freiburg.de+49 761 270-42730

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026