An interventional study of Cochlear implantation and CROS or BiCROS device fitting in Unilateral Hearing Loss and Asymmetric Hearing Loss, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Today, unilateral hearing loss must be assessed and managed just as bilateral hearing loss is. It is recommended to consider the auditory difficulties caused by the loss of stereophonic hearing and to offer auditory rehabilitation as early as possible. Studies show that hearing devices can be effective in certain cases and for specific auditory modalities. The prognostic factors for successful hearing aid adaptation are linked to early intervention and the presence of residual hearing (using a BiCROS system). However, the cochlear implant remains the only device capable of potentially restoring contralateral auditory function in cases of single-sided deafness (SSD) and severe to profound unilateral hearing loss with asymmetrical deafness
Unilateral congenital deafness has significant repercussions on a child's development. Numerous studies on this population have demonstrated its impact on speech and language development, as well as academic progress. Monaural hearing increases the risk of listening fatigue and causes considerable difficulty in sound localization and speech perception in noisy environments, as these abilities rely on binaural hearing.
Recent research has also indicated that in children with unilateral deafness, the better ear may be affected by sensory deprivation in the impaired ear. Despite these substantial effects, treatment options for these children remain limited. Traditional hearing aids are insufficient to restore functional hearing in cases of profound deafness. The only routinely available options are a Bone-Anchored Hearing Aid (BAHA) or a Contralateral Routing of Sound (CROS) system. While these devices allow the signal from the affected side to be transmitted to the better ear, they do not restore binaural hearing, unlike cochlear implants (CIs).
A growing body of evidence has demonstrated the benefits of cochlear implantation on speech perception in noise and sound localization in adults. However, in France, CIs are currently indicated only for cases of severe to profound unilateral deafness associated with debilitating tinnitus, and only when alternative treatments-such as CROS systems and osseointegrated hearing aids-have failed in children. While studies suggest that children may achieve similar outcomes, no clinical research has been conducted. This study aims to evaluate functional performance and neurological correlates in unilaterally implanted children with unilateral hearing loss, in comparison with their hearing-aided peers
51 studies on the registry are indexed under Hearing Loss, Unilateral; 7 are open to participants now.
This study's planned enrollment of 36 is close to the median of 35 across 35 interventional studies indexed under Hearing Loss, Unilateral.
Browse Hearing Loss, Unilateral studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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The criteria were revised on the registry on Oct 22, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Unilateral is defined by severe to profound hearing loss in the affected ear (thresholds > 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and normal hearing in the better ear (thresholds ≤ 25 dB between 500-4000 Hz, established by audiometry or ASSR).
Asymmetric is defined by severe to profound hearing loss in the weaker ear (thresholds > 70 dB at ≥ 4 frequencies, established by audiometry or ASSR) and mild hearing loss in the better ear (thresholds between 30-40 dB at ≤ 4 frequencies, established by audiometry or ASSR).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Fitted with a cochlear implant
Device: CROS or BiCROS device fitting · Diagnostic Test: French simplified matrix test (FraSimat) · Diagnostic Test: Sound localization test (ERKI) · Diagnostic Test: Cortical Auditory Evoked Potentials (PEAc) · Other: Speech, Spatial and Qualities of Hearing Scale (SSQ) · Other: Peabody Picture Vocabulary Scale (PPVT or EVIP in french) · Other: NEPSY-II (A Developmental Neuropsychological Assessment) · Other: Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS)
Fitted with a CROS or BiCROS system, depending on the type of hearing loss
Device: Cochlear implantation · Diagnostic Test: French simplified matrix test (FraSimat) · Diagnostic Test: Sound localization test (ERKI) · Diagnostic Test: Cortical Auditory Evoked Potentials (PEAc) · Other: Speech, Spatial and Qualities of Hearing Scale (SSQ) · Other: Peabody Picture Vocabulary Scale (PPVT or EVIP in french) · Other: NEPSY-II (A Developmental Neuropsychological Assessment) · Other: Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS)
During surgery at 8 weeks after inclusion, cochlear implant is implanted
At 8 weeks after inclusion, CROS or BICROS (depending on the type of hearing loss) is fitting
The FraSimat is an adaptive test that measures speech intelligibility in noise. It consists of 14 sentences of 3 words each, recorded in the presence of background noise. The FraSimat will be performed in two different configurations in relation to the source of the signal and noise before implantation or fitting, and 1, 2, 3 and 4 months after.
ERKI for German "Erfassung des Richtungshörens für Kinder" is an automated test that assesses spatial localization skills. The test is performed with the child seated facing a semi-circular table, surrounded by a set of 5 loudspeakers arranged 1 meter apart. The test consists of 5 stimuli, followed by 42 trials. Following the presentation of each stimulus, the child must turn a control knob and direct the LED light to the point where he or she has perceived it. The child validates his or her response by pressing the button. ERKI is evaluated before implantation or fitting, and 1, 2 and 3 months after.
The recording of Auditory Cortical Evoked Potentials provides an objective means of assessing the maturation of the auditory system and its ability to process auditory signals. AEPs consist of a series of cortical responses to an auditory stimulus. PEAc are assessed using a non-invasive EEG recording, made under quiet wakefulness. Four surface electrodes are glued to the patient's skull: one on the vertex, one on the forehead, and one on each mastoid. The latency (msec) and amplitude (mV) values of each of the four component waves will be analyzed. PEAc is evaluated before implantation or fitting, and 3 and 4 months after.
The Speech, Spatial and Qualities of Hearing Scale is a questionnaire for subjective evaluation of listening performance in everyday listening situations. The parent version is adapted for parents of hearing-impaired children. SSQ is evaluated before implantation or fitting, and 4 months after.
Peabody Picture Vocabulary Scale assesses the extent of French listening vocabulary acquired by the child. The PPVT is designed for patients aged from 2 years and 6 months to 18 years. The raw score is the number of images correctly identified. Peabody Picture Vocabulary Scale is evaluated before implantation or fitting, and 4 months after.
The NEPSY-II (A Developmental Neuropsychological Assessment) is a battery of neuropsychological tests designed to assess children's skills in 6 major neuropsychological domains. The various tests are validated for the age range indicated in brackets, and will be used for patients aged 5 and over. NEPSY-II is evaluated before implantation or fitting, and 4 months after.
PedsQL MFS is a questionnaire used to assess subjective experiences of fatigue. The questionnaire consists of 18 items The parent version is adapted for parents of hearing-impaired children. PedsQL MFS is evaluated before implantation or fitting, and 4 months after.
French simplified matrix test (FraSimat) SAABAN condition at Month 18
The primary endpoint is intervention success, defined as an increase ≥ 6dB SNR (Signal-to-Noise Ratio) at 18 months compared with the value at the pre-intervention visit. It is assessed in the SAABAN condition, i.e. by presenting the signal (speech) to the better ear and the noise to the better ear.
Time frame: 18 months after implantation or fitting
French simplified matrix test (FraSimat) SAABAN condition at Month 12
Evolution of FraSimat score in Signal to Noise Ratio at 12 months compared with the value at the pre-intervention visit. It is assessed in the SAABAN condition, i.e. by presenting the signal (speech) to the better ear and the noise to the better ear.
Time frame: 12 months after implantation or fitting
French simplified matrix test (FraSimat) S0B0 condition at Month 18
Evolution of FraSimat score in Signal to Noise Ratio at 18 months compared with the value at the pre-intervention visit. It is assessed in the S0B0 condition, i.e. signal and noise at 0° to the head (in front).
Time frame: 18 months after implantation or fitting
French simplified matrix test (FraSimat) S0B0 condition at Month 12
Evolution of FraSimat score in Signal to Noise Ratio at 12 months compared with the value at the pre-intervention visit. It is assessed in the S0B0 condition, i.e. signal and noise at 0° to the head (in front).
Time frame: 12 months after implantation or fitting
Sound localization test (ERKI) Month 12
Evolution of RMSE (root-mean-square deviation) in the ERKI (Assessment of directional hearing for children) test between the pre-intervention visit and Month 12
Time frame: 12 months after implantation or fitting
Sound localization test (ERKI) Month 18
Evolution of RMSE (root-mean-square deviation) in the ERKI (Assessment of directional hearing for children) test between the pre-intervention visit and Month18
Time frame: 18 months after implantation or fitting
Questionnaire Speech, Spatial and Qualities of Hearing Scale (SSQ, version parent)
Evolution of SSQ total score and sub-scores between the pre-intervention visit and Month 18.
Time frame: 18 months after implantation or fitting
Peabody Picture Vocabulary Scale (PPVT or EVIP in french)
Change in standardized PPVT/EVIP score from pre-intervention visit to Month 18
Time frame: 18 months after implantation or fitting
NEuroPSYchological assessment NEPSY-II
Change in NEPSY-II score between pre-intervention visit and Month 18 in patients aged 5 and over at inclusion.
Time frame: 18 months after implantation or fitting
Cortical Auditory Evoked Potentials (PEAc) Month 12
Evolution of latencies and amplitudes between the pre-intervention visit and Month12 for waves P1, N1, P2, N2. Evolution of the interaural difference in P1 latency between the pre-intervention visit and Month 12 (experimental group only).
Time frame: 12 months after implantation or fitting
Cortical Auditory Evoked Potentials (PEAc) Month 18
Evolution of latencies and amplitudes between the pre-intervention visit and Month18 for waves P1, N1, P2, N2. Evolution of the interaural difference in P1 latency between the pre-intervention visit and Month 18 (experimental group only).
Time frame: 18 months after implantation or fitting
Quality of life : Pediatric Quality of Life Inventory Multidimensional Fatigue Scale (PedsQL MFS)
Evolution of the PedsQL MFS total score and sub-scores between the pre-intervention visit and Month18.
Time frame: 18 months after implantation or fitting
Device satisfaction
Duration of device use via datalogging of implant cochlear or hearing system
Time frame: Up to 18 months after implantation or fitting
Number of adverse events
Expected implant-related adverse events may include Facial paralysis or paresis, Dizziness, Meningitis, Skin complications, Implant failure The presence of one or more of these effects will be evaluated at each ENT (ear nose throat) assessment.
Time frame: Up to 18 months after implantation or fitting
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Jan 2029, 28 months after the start.
Of 24 interventional studies with no phase under Hearing Loss, Unilateral, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 83. This study's planned 28 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Mar 2026 → Sep 2026, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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