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AzTrials

Profound DeafnessAlgo FréqNCT04888143

Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.

A study testing questionnaires and Evolutionary algorithm in people with Profound Deafness, run by Centre Hospitalier Universitaire Dijon 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

360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have profound or total impairment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Profound Deafness
What is being tested?
questionnaires and Evolutionary algorithm
How many people
18 participants
Where
1 siteFrance
Study dates
8 Jun 2020to 9 Nov 2020
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

  • Person having given his or her non-opposition
  • Implanted post lingual profound deafness and one functional contralateral ear (normal hearing or mild to severe hearing loss with hearing aids)
  • Have more than 6 months of experience with cochlear implants
  • Daily use of their two hearing aids for more than 6 hours a day

Who cannot join

  • person subject to a legal protection measure (guardianship, tutorship)
  • person subject to a measure of judicial control
  • pregnant, parturient or breastfeeding woman
  • adult unable to express consent
  • minor

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Dijon Bourgogne

    Dijon, 21000

Other trials in France

About this study

360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have profound or total impairment.

Cochlear implants are indicated in severe to profound deafness in some cases. The principle of the cochlear implant is to directly stimulate the fibres of the auditory nerve via electrodes inserted into the cochlea. It stimulates the auditory nerve and sends electrical impulses to the brain where they are interpreted as sounds.

Read more

The steps in hearing rehabilitation are surgical placement of the cochlear implant, activation, and follow-up adjustments.

There is no formal consensus on the exact adjustment procedures during activation or follow-up, but principles are followed depending on the cochlear implant adjustment centers (jack). All centers focus on sound intensity adjustments to achieve the goals of tonal audiometry in open-field silence with cochlear implant alone between 20 and 40 db (30 db most frequently). However, it is common practice to observe that this means of assessment does not really represent the performance of the individual because hearing a sound does not mean that someone will be able to recognize it and interpret it. Some of the patients who achieve these goals have difficulty hearing well in a noisy environment. Speech audiometry in silence and especially in noise would be a better reflection of patient needs.

Bimodal hearing is having a cochlear implant and a contralateral hearing aid. In cochlear implants, having bimodal binaural hearing improves the patients ability to understand speech in silent and noisy contexts. It should thus be considered when a second cochlear implant is not indicated in the contralateral ear.

It has been shown that intelligibility and musical perception are altered when the frequency allocations are different from the manufacturer's default frequency allocations. The possible redundancy between the acoustic and electrical information on the contralateral ear can lead to metallic distortion of the voice, which is perceived as less natural. This is due to a different stimulation of the cochlear tonotopic zones concerning conversational frequencies, between the implanted side and the device side. However, the frequency distribution is not subject to adjustment in current practice. A modification of the frequency distribution is possible on cochlear implants, which could improve the intelligibility and comfort of the implanted patient.

This working hypothesis will be studied, and a simple protocol for frequency reallocation of the cochlear implant will be developed to optimize the daily hearing performance of the implanted patients. An evolutionary algorithm will be used. The search for new adjustment solutions will be carried out within the safety limits imposed by the adjusters (detection and comfort loudness threshold).

Being tested
questionnaires, Evolutionary algorithm

What participants receive

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

  • questionnairesOther

    evaluation of hearing performance and quality of life questionnaires

  • Evolutionary algorithmOther

    application of the evolutionary algorithm and customized frequency allocation on a separate program.

What is being measured

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

  1. percentage of words recognized

    Measurement of intelligibility in noise in bimodal situations

    Measured: Through study completion, an average of 2 months

Timeline

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

  1. First posted17 May 2021
  2. Study start8 Jun 2020
  3. Primary completion9 Nov 2020
  4. Study completion9 Nov 2020

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888143
Sponsor's protocol ID
BOZORG SCHEIN 2019
Acronym
Algo Fréq
Status last verified
Jan 2026
First submitted
11 May 2021
Last updated
29 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Saadoun A, Schein A, Pean V, Legrand P, Aho Glele LS, Bozorg Grayeli A. Frequency Fitting Optimization Using Evolutionary Algorithm in Cochlear Implant Users with Bimodal Binaural Hearing. Brain Sci. 2022 Feb 11;12(2):253. doi: 10.3390/brainsci12020253.

    PubMed 35204015

Questions about this trial

What is this clinical trial studying?

A study testing questionnaires and Evolutionary algorithm in people with Profound Deafness, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 5 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 29 Jan 2026. 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?

percentage of words recognized (time frame: Through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04888143, which also lists 1 linked publication.

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 29 Jan 2026.

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