An interventional study of Satisfaction questionnaire and Speech intelligibility in quiet in Sensorineural Hearing Loss and Cochlear Hearing Loss, sponsored by Oticon Medical. Completed at 9 sites in France. Per ClinicalTrials.gov, last updated 2023-03-23.
Sponsored by Oticon Medical · Not applicable, Interventional, and Treatment
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Among 11 studies in Hearing Loss, Sensorineural by Oticon Medical — 1 open to participants now, 1 under way, none of them phase 3. Hearing Loss, Sensorineural · Oticon Medical.
Among the 11 studies in Hearing Loss, Sensorineural by Oticon Medical, this one is one of 4 that started in 2017, is one of 9 with no phase, and was the 4th registered.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 101 are open to participants now.
Browse Hearing Loss, Sensorineural studies →1 of the 11 studies in Hearing Loss, Sensorineural by Oticon Medical is open now. Recruiting first, the newest first:
Oticon Medical
Ages 18+
Of the 70 Hearing Loss, Sensorineural studies recruiting now, 39 (56%) set no upper age limit and 19 (27%) stop at 75 or younger; 26 take children under 18; 17 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 4 started in 2017.
This study's enrollment of 98 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Median enrollment 17 across the 9 interventional studies, 55 across the 2 observational. Of the 7 that completed or were terminated, 1 (14%) have results posted.
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Oticon Medical is the lead sponsor of 45 studies on the registry; 6 are open to participants now.
1 of the studies in Hearing Loss, Sensorineural by Oticon Medical that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05154188Oticon MedicalPost Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users | 2027-02 |
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Among the 11 studies in Hearing Loss, Sensorineural by Oticon Medical, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.
Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system, including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1). This new speech processor automatically detects and adapts to the sound environment, increasing the ease of listening in all situations. A second version of this speech processor has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal processing characteristics and the "sound" delivered to the patient is similar. However, the Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries...). Some improvements available on the Neuro 2 may be particularly interesting for children.
The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1.
The participants come at the hospital for three visits. The Neuro 1 is evaluated during the first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after V1) and the third (V3, 3 months after V2).
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.
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.
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.
Visit 1: Satisfaction questionnaire on Neuro 1 Speech intelligibility in quiet on Neuro 1 Speech intelligibility in noise on Neuro 1 VRB (Vocale Rapide dans le Bruit) on Neuro 1 Visit 2 (15 days after V1): Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2 Visit 3 (3 months after V2): Satisfaction questionnaire on Neuro 2 Speech audiometry in quiet on Neuro 2 Speech audiometry in noise on Neuro 2 VRB (Vocale Rapide dans le Bruit) on Neuro 2
Other: Satisfaction questionnaire · Behavioral: Speech intelligibility in quiet · Behavioral: Speech intelligibility in noise · Behavioral: VRB (Vocale Rapide dans le Bruit)
Visit 1 Satisfaction questionnaire on Neuro 1 Visit 2 (15 days after V1): Satisfaction questionnaire on Neuro 2 Visit 3 (3 months after V2): Satisfaction questionnaire on Neuro 2 The questionnaires have to be filled in by the parents. The child can participate in the completion of the questionnaire if he is willing and understands the questions.
Other: Satisfaction questionnaire
Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. The noise corresponds to a cocktail party presented at +10 dB SNR (Speech on Noise Ratio). At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
Speech intelligibility in noise measured with the test VRB (Vocale Rapide dans le Bruit, French version of the Quick Sin). This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB. 3 lists are presented. Speech signals are presented at 60 dB SPL.
Also known as: french Quick SIN
Satisfaction questionnaire
The listener has to rate his appreciation of the Neuro 1 and Neuro 2 device and the sound quality on 7 points scale. The outcome measure corresponds to averaged score. The questionnaire has been developed by Oticon Medical to investigate satisfaction patient for their current and future speech processors. This questionnaire is not validated in the literature.
Time frame: 15 minutes
Speech comprehension in quiet
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
Time frame: 15 mins
Speech comprehension in Noise
The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of words and the percentage of phonemes correctly repeated. This double scoring is used to avoid floor or ceiling effects that could happen with only one of these measures.
Time frame: 15 mins
French Quick Sin
This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB.
Time frame: 5 mins
Plan to share: No
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Ran from Oct 2017 to primary completion in Jan 2019, 15 months.
Of 80 industry-sponsored interventional studies with no phase under Hearing Loss, Sensorineural, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 23. This study's 15 months is close to that.
Counting every sponsor, half of 162 studies reached it within 22 months; a quarter within 6 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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