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Sensorineural Hearing Loss, BilateralNCT05754918

Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Fitting With or Without Fine Structure Coding

A study testing TnoFs then TFS (Cochlear implant) and TFS then TnoFS (Cochlear implant) in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Brief Summary: Main objective: Comparison of a tonotopy based fitting strategy (TFS) with fine structure coding to a tonotopy based fitting strategy without fine structure coding (TnoFS) for speech perception in noise. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sensorineural Hearing Loss, Bilateral
What is being tested?
TnoFs then TFS (Cochlear implant) and TFS then TnoFS (Cochlear implant)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteFrance
Study dates
15 Apr 2023to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patient (>= 18 years old) speaking French
  • Patient who fulfils the criteria for cochlear implantation
  • Total hearing loss for less than 5 years

Who cannot join

  • retro-cochlear pathology: auditory neuropathy, vestibular schwannoma
  • patient with residual hearing < 60 dB HL at 250 Hz and < 80 dB HL at 500 Hz

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU Rennes

    Rennes, 35000

Other trials in France

About this study

Official title: Comparison of Speech Understanding and Melodic Perception of Two Tonotopic Fitting Modalities With or Without Fine Structure in Newly Implanted Cochlear Patients: Randomized Double-blind Crossover Study.

Brief Summary:

Main objective:

Comparison of a tonotopy based fitting strategy (TFS) with fine structure coding to a tonotopy based fitting strategy without fine structure coding (TnoFS) for speech perception in noise.

Secondary objectives:

Comparison of TFS to TnoFS for the perception of musical elements (contour test).

Comparison of TFS to TnoFS for speech perception in quiet

Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces.

Comparison of TFS to TnoFS for the melodic recognition

Read the detailed description

Introduction: Cochlear implantation allows the rehabilitation of profound bilateral deafness, restoring speech perception and verbal communication when the traditional hearing aid no longer provides satisfactory hearing gain (Nimmons et al.).

A cochlear implant includes an electrode array and its functioning is based on the principle of cochlear tonotopy: each electrode encodes a frequency spectrum according to its position in the cochlea (high frequencies are assigned to the basal electrodes and low frequencies to the apical electrodes). The cochlear implant thus breaks down the frequency spectrum into a number of frequency bands via bandpass filters corresponding to the number of electrodes in the implant. During the fitting these bands can be modified by the audiologist.

The fitting software developed by the manufacturers proposed a default fitting with a lower limit between 100 and 250 Hz according to the brands and an upper limit of about 8500 Hz. The frequency bands assigned to each electrode follow a logarithmic scale with the high frequencies for the basal electrodes and the low frequencies for the apical electrodes. This distribution takes into account the number of active electrodes but does not take into account the anatomy and the natural cochlear tonotopy specific to each patient.

Several studies have analyzed the anatomical variations of the cochlear dimensions: size of the cochlea and the ratio between the contact surfaces of the electrodes with the cochlea are variable from one patient to another (Stakhovskaya O et al., P. Pelliccia et al.).

The insertion depth during surgery is also variable due to parameters related to the patients as well as to the operator, which seems to impact the understanding of speech in noise (Deep electrode insertion and sound coding in cochlear implants - Ingeborg Hochmair et al.).

Mathematical algorithms have recently been developed to estimate the cochlear tonotopy of each patient from a CT scan assessment (Jiam et al., Sridhar et al.). CT imaging of the implanted ear combined with 3D reconstruction software, provides cochlear length measurements (Cochlear length determination using Cone Beam Computed Tomography in a clinical setting - Würfel et al .). Using this approach it is possible to measure the position of each electrode relative to the cochlear apex. These measurements are applied to the modified Greenwood equation to obtain the tonotopic frequency for each electrode and to determine for each patient a fitting based on the tonotopy of each electrode.

Conventional stimulation strategies in cochlear implants (e.g. advanced combination encoder (ACE), continuous interleaved sampling (CIS)) use the place of the electrode to code the frequency by sending low frequency information on the apical electrodes and high frequency information on the basal electrodes. The stimulation rate of the electrodes is constant. The pitch is only partially transmitted by these conventional strategies which would explain the poor results of cochlear implants in the perception of music. In the FineHearing strategy of the MED-EL implant, the rate of stimulation on the low-frequency electrodes is related to the frequency of the sound and makes it possible to code the frequency information temporally.

Rader \& al. 2016 have studied the contribution of adding to the tonotopic coding of the frequency (classical strategy) a temporal coding of the information by varying the stimulation rate. The results obtained show that providing this frequency information by time coding makes it possible to obtain perceived pitch much closer to the expected pitch (of normal-hearing) and less variability, especially at low frequencies. With fixed stimulation rate (classical strategy) low frequencies are poorly coded, whereas with the variable stimulation rate they are better coded. In addition, Landsberger et al. [2018] studied in six subjects with a MED-EL implant the perception of a temporal coding according to the position of the electrodes with a long insertion: middle or apical position. The results seem to show that the temporal coding of the frequency would be more reliable than the spatial coding (related to the position of the electrode) at the apex, and the reverse on the electrodes in the middle position. Studies have shown that the FineHearing strategy can provide benefits over the classic High-Definition Continuous Interleaved Sampling (HDCIS) strategy in tasks involving the fundamental F0 such as speech recognition in noise (after a certain learning time) [Kleine Punte \& al. 2014 ; Vermeire \& al. 2010], the perception of music [Roy \& al. 2015 ; Roy \& al. 2016] or the perceived quality of pitch [Müller \& al. 2012].

MED-EL's FineHearing coding strategy with a tonotopic-based fitting could therefore allow better transmission of pitch and in particular improve the speech recognition in noise compared to the same tonotopic-based fitting without FineHearing coding.

Main objective:

Comparison of a tonotopy based fitting strategy (TFS) with fine structure coding to a tonotopy based fitting strategy without fine structure coding (TnoFS) for speech perception in noise.

Secondary objectives:

Comparison of TFS to TnoFS for the perception of musical elements (contour test).

Comparison of TFS to TnoFS for speech perception in quiet

Comparison of TFS to TnoFS for the qualitative preference for the listening of musical pieces.

Comparison of TFS to TnoFS for the melodic recognition

Plan of the study:

It is a prospective open monocentric randomized crossover study: measures will be done on the patient at 6 weeks and 12 weeks post-activation.

Being tested
TnoFs then TFS (Cochlear implant), TFS then TnoFS (Cochlear implant)
Keywords
cochlear implant strategy, tonotopy-based fitting, fine structure coding
Medical subject headings
Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TnoFs then TFS (Cochlear implant)Device

    Cochlear implant with tonotopy-based fitting without fine structure coding then with fine structure coding

  • TFS then TnoFS (Cochlear implant)Device

    Cochlear implant with tonotopy-based fitting with fine structure coding then without fine structure coding

Study groups in NCT05754918
Study groupRoleWhat they receive
TnoFS then TFSActive comparatorCochlear Implant with TnoFS first during 6 weeks then with TFS during 6 weeks
Receives: Device: TnoFs then TFS (Cochlear implant)
TFS then TnoFSActive comparatorCochlear Implant with TFS first during 6 weeks then with TnoFS during 6 weeks
Receives: Device: TFS then TnoFS (Cochlear implant)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Speech recognition in noise

    The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

    Measured: at 6 weeks post-activation

  2. Speech recognition in noise

    The speech recognition in noise is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%). Signal-noise-ratios of 9, 6, 3 and 0 dB will be tested with speech at 65 dB SPL.

    Measured: at 12 weeks post-activation

Secondary outcomes (8)
  1. Speech recognition in quiet

    The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).

    Measured: at 6 weeks post-activation

  2. Speech recognition in quiet

    The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and The speech recognition in quiet is evaluated with syllabic list of 40 phonemes. The patient has to recognize 20 syllables. The phonemes are scored: each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).

    Measured: at 12 weeks post-activation

  3. Melodic contour test

    The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies correspond to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).

    Measured: at 6 weeks post-activation

  4. Melodic contour test

    The test stimuli of the melodic contour test (Galvin et al. 2007) are melodic contours composed of 5 notes of equal duration whose frequencies correspond to musical intervals. Nine distinct musical patterns have to be identified by the patient. Each good answer is scored 1 yielding a total between 0 and 1 (or 0% and 100%).

    Measured: at 12 weeks post-activation

  5. Qualitative measure of music

    The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sound, loudness.

    Measured: at 6 weeks post-activation

  6. Qualitative measure of music

    The Gabrielsson scale (1988) is used to evaluate perceived sound quality as a multidimensional phenomenon, that is composed of a number of separate perceptual dimensions. Eight perceptual dimensions are evaluated: clarity, fullness, brightness vs dullness, hardness/sharpness vs softness, spaciousness, nearness, extraneous sound, loudness.

    Measured: at 12 weeks post-activation

  7. Melodic recognition

    Each participant had to choose, among ten pieces (List in Figure 6), two pieces of which he knew the melody well. The songs were each played twice for 40 seconds.

    After each listening, the participant had to indicate on a visual analogical scale the level of recognition of the melody. The minimum, score 0, means that the music sample was not recognized at all. The maximum, score 10, means that the extract has been fully recognized.

    Measured: at 6 weeks post-activation

  8. Melodic recognition

    Each participant had to choose, among ten pieces (List in Figure 6), two pieces of which he knew the melody well. The songs were each played twice for 40 seconds.

    After each listening, the participant had to indicate on a visual analogical scale the level of recognition of the melody. The minimum, score 0, means that the music sample was not recognized at all. The maximum, score 10, means that the extract has been fully recognized.

    Measured: at 12 weeks post-activation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start15 Apr 2023
  3. Primary completion1 Dec 2024
  4. Study completion1 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Two arms A and B: Arm A: patient's fitting with tonotopy-based fitting without fine structure coding (TnoFS) --\> 6 weeks use --\> tests and patient's fitting with tonotopy-based fitting with fine structure coding (TFS) --\> 6 weeks use --\> tests; Arm B: patient's fitting with TFS --\> 6 weeks use --\> tests and patient's fitting with TnoFS --\> 6 weeks use --\> tests
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05754918
Sponsor's protocol ID
MED_EL_COFRET_Rennes_study
Status last verified
Apr 2025
First submitted
22 Feb 2023
Last updated
8 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TnoFs then TFS (Cochlear implant) and TFS then TnoFS (Cochlear implant) in people with Sensorineural Hearing Loss, Bilateral, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech recognition in noise (time frame: at 6 weeks post-activation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.

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