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WithdrawnNCT04357704APPICUpdated Aug 3, 2025

Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlear Implant User.

An interventional study of S0N0 and S0N500 in Hearing Loss, Cochlear, sponsored by Oticon Medical. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.

Sponsored by Oticon Medical · Not applicable, Interventional, and Basic science

Why this study was withdrawn
Delay in setting up the study.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study summary

The aim of the study is to evaluate the interaural time difference (ITD) benefit in patients with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

Read the detailed description

Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization.

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Conditions studied

  • Hearing Loss, Cochlear

Keywords

  • Iteraural Time Difference
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In context

Hearing Loss, Sensorineural

371 studies on the registry are indexed under Hearing Loss, Sensorineural; 112 are open to participants now.

Browse Hearing Loss, Sensorineural studies →

Lead sponsor

Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Fluent in local language
  • Normal hearing listener:
  • pure tone threshold > 25dB from 125Hz to 12kHz
  • Cochlear implant recipient
  • bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
  • Digisonic SP® cochlear implants user

Exclusion criteria

Exclusion Criteria:

  • binaural sensitivity threshold \< 1000µs
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    bilateral cochlear implant recipients

    Other: S0N0 · Other: S0N500 · Other: S-500N500 · Other: S0N1000 · Other: S0Nuncorr

  • Active comparator
    normal hearing listners

    Other: S0N0 · Other: S0N500 · Other: S-500N500 · Other: S0N1000 · Other: S0Nuncorr

Interventions

  • OtherS0N0

    (no ITD)

  • OtherS0N500

    (ITD +500µs on noise)

  • OtherS-500N500

    (ITD -500µs on signal and +500 µs on noise)

  • OtherS0N1000

    (ITD + 1000 µs on noise)

  • OtherS0Nuncorr

    (no ITD cue, with uncorrelated stimulation frame)

06

What researchers measure

Primary outcomes

  1. speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue

    SRT is used as an outcome measure to quantify the acuity for speech perception in noise with Interaural Time Difference between the two ears. Signal recognition in a background noise is assessed the following conditions S0N0, S0N500, S0N1000, S-500N500 et S0Nuncorr. The noise level is constant at 65 dB SPL, the signal level is modified in the adaptive procedure in order to converge towards a score of 50% of correct response.

    Time frame: day 0

Secondary outcomes

  1. speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners

    SRT is used as an outcome measure to quantify the acuity for speech perception in noise without Interaural Time Difference between the two ears.

    Time frame: day 0

  2. ITD sensitivity in bilateral cochlear implant user

    Speech signal and noise are presented at 65dB SPL. Participant adjusts the Interaural Time Difference between the speech signal and noise between -1000 and +1000µs. Participant moves the cursor on the interface until he/she hears a difference in sound.

    Time frame: day 0

  3. Preferred jitter in bilateral cochlear implant user

    Speech signal and noise are presented at 65dB SPL. Participant adjusts the jitter of the train pulse timing from 0 to +1000µs to improve the Interaural Time Difference.

    Time frame: day 0

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04357704
Lead sponsor
Oticon Medical
Responsible party
Sponsor
First posted
Apr 22, 2020
Start date
Apr 1, 2019 (estimated)
Primary completion
Jun 1, 2019 (estimated)
Completion
Sep 1, 2019 (estimated)
Last update
Aug 3, 2025

Study contacts

Nicolas Guevara, MD
principal investigator · Hospital University Nice-IUFC
Alexis Bozorg-Grayeli, MD
principal investigator · Hospital University Dijon-François Mitterrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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