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Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

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ClinicalTrials.gov Identifier: NCT03288753
Recruitment Status : Enrolling by invitation
First Posted : September 20, 2017
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Cochlear Hearing Loss Other: Satisfaction questionnaire Behavioral: Speech intelligibility in quiet Behavioral: Speech intelligibility in noise Behavioral: VRB (Vocale Rapide dans le Bruit) Not Applicable

Detailed Description:

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adults and children above 14 years old

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
Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.

Behavioral: Speech intelligibility 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 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.

Behavioral: Speech intelligibility 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 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.

Behavioral: VRB (Vocale Rapide dans le Bruit)
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.
Other Name: french Quick SIN

Experimental: children up to 14 years old

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.




Primary Outcome Measures :
  1. Satisfaction questionnaire [ Time Frame: 15 minutes ]
    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.


Secondary Outcome Measures :
  1. Speech comprehension in quiet [ Time Frame: 15 mins ]
    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.

  2. Speech comprehension in Noise [ Time Frame: 15 mins ]
    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.

  3. French Quick Sin [ Time Frame: 5 mins ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • vulnerable patients, at the exception of children (pregnant women, persons under guardianship)
  • No Social security affiliation
  • non-compliant patient

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288753


Locations
France
Hôpital Pellegrin
Bordeaux, France, 33000
Hôpital Roger Salengro
Lille, France, 59037
Hôpital Edouard Herriot
Lyon, France, 69003
CHRU de Nancy Hôpital central
Nancy, France, 54035
CHU de Nantes Hôtel-Dieu
Nantes, France, 44093
CHU Nice - Institut Universitaire de la Face et du Cou
Nice, France, 06103
Hôpitaux Pédiatriques de Nice CHU-Lenval
Nice, France, 06200
Hôpital Pitié Salpêtrière - APHP
Paris, France, 75013
Hôpital Necker-Enfants Malades
Paris, France, 75015
Sponsors and Collaborators
Oticon Medical
Investigators
Principal Investigator: Christophe Vincent, MD, PROF Hôpital Roger Salengro CHRU de Lille

Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT03288753     History of Changes
Other Study ID Numbers: PIC_14
First Posted: September 20, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oticon Medical:
Cochlear implant

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms