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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00003-42 | Other Identifier | ID-RCB Number |
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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear implant | Experimental | Fitted with a cochlear implant |
|
| CROS or biCROS system | Active Comparator | Fitted with a CROS or BiCROS system, depending on the type of hearing loss |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implantation | Device | During surgery at 8 weeks after inclusion, cochlear implant is implanted |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months after implantation or fitting |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after implantation or fitting |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nathalie LOUNDON, MD, PhD | Contact | 01 71 39 67 82 | +33 | natalie.loundon@aphp.fr |
| Laure CHOUPEAUX, Project manager | Contact | 01 44 38 17 11 | +33 | laure.choupeaux@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nathalie LOUNDON, MD, PHD | Unité d'Audiophonologie et d'Implantation cochléaire - Service d'ORL et chirurgie cervico-faciale Hôpital Necker. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Audiophonology Unit of the Ear, Nose and Throat (ENT) Department ("Oto-rhino-laryngologie (ORL) et chirurgie cervico-faciale") | Recruiting | Paris | 75014 | France |
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| CROS or BiCROS device fitting | Device | At 8 weeks after inclusion, CROS or BICROS (depending on the type of hearing loss) is fitting |
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| French simplified matrix test (FraSimat) | Diagnostic Test | 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. |
|
| Sound localization test (ERKI) | Diagnostic Test | 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. |
|
| Cortical Auditory Evoked Potentials (PEAc) | Diagnostic Test | 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. |
|
| Speech, Spatial and Qualities of Hearing Scale (SSQ) | Other | 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. |
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| Peabody Picture Vocabulary Scale (PPVT or EVIP in french) | Other | 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. |
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| NEPSY-II (A Developmental Neuropsychological Assessment) | Other | 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. |
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| Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL MFS) | Other | 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. |
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| 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). | 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). | 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 | 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 | 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. | 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 | 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. | 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). | 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). | 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. | 18 months after implantation or fitting |
| Device satisfaction | Duration of device use via datalogging of implant cochlear or hearing system | 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. | Up to 18 months after implantation or fitting |
| ID | Term |
|---|---|
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019929 | Cochlear Implantation |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
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