Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors
Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors
1 other identifier
interventional
98
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2017
CompletedFirst Posted
Study publicly available on registry
September 20, 2017
CompletedStudy Start
First participant enrolled
October 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 11, 2019
CompletedMarch 23, 2023
March 1, 2023
1.3 years
September 18, 2017
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
15 minutes
Secondary Outcomes (3)
Speech comprehension in quiet
15 mins
Speech comprehension in Noise
15 mins
French Quick Sin
5 mins
Study Arms (2)
Adults and children above 14 years old
EXPERIMENTALVisit 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
children up to 14 years old
EXPERIMENTALVisit 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- informed consent
- Native French speaker or fluent French speaker
- Patient already fitted with one or two speech processor Neuro 1 for at least 5 months
You may not qualify if:
- vulnerable patients, at the exception of children (pregnant women, persons under guardianship)
- No Social security affiliation
- non-compliant patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (9)
Hôpital Pellegrin
Bordeaux, 33000, France
Hôpital Roger Salengro
Lille, 59037, France
Hôpital Edouard Herriot
Lyon, 69003, France
CHRU de Nancy Hôpital central
Nancy, 54035, France
CHU de Nantes Hôtel-Dieu
Nantes, 44093, France
CHU Nice - Institut Universitaire de la Face et du Cou
Nice, 06103, France
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, 06200, France
Hôpital Pitié Salpêtrière - APHP
Paris, 75013, France
Hôpital Necker-Enfants Malades
Paris, 75015, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe Vincent, MD, PROF
Hôpital Roger Salengro CHRU de Lille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2017
First Posted
September 20, 2017
Study Start
October 2, 2017
Primary Completion
January 11, 2019
Study Completion
January 11, 2019
Last Updated
March 23, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share