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Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

Primary Purpose

Sensorineural Hearing Loss, Cochlear Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Satisfaction questionnaire
Speech intelligibility in quiet
Speech intelligibility in noise
VRB (Vocale Rapide dans le Bruit)
Sponsored by
Oticon Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Cochlear implant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Pellegrin
  • Hôpital Roger Salengro
  • Hôpital Edouard Herriot
  • CHRU de Nancy Hôpital central
  • CHU de Nantes Hôtel-Dieu
  • CHU Nice - Institut Universitaire de la Face et du Cou
  • Hôpitaux Pédiatriques de Nice CHU-Lenval
  • Hôpital Pitié Salpêtrière - APHP
  • Hôpital Necker-Enfants Malades

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adults and children above 14 years old

children up to 14 years old

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 18, 2017
Last Updated
March 22, 2023
Sponsor
Oticon Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03288753
Brief Title
Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors
Official Title
Comparison of Patient Satisfaction and Audiological Performance Between Neuro 1 and Neuro 2 Speech Processors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
January 11, 2019 (Actual)
Study Completion Date
January 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oticon Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Cochlear Hearing Loss
Keywords
Cochlear implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adults and children above 14 years old
Arm Type
Experimental
Arm Description
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
Arm Title
children up to 14 years old
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Satisfaction questionnaire
Intervention Description
Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.
Intervention Type
Behavioral
Intervention Name(s)
Speech intelligibility in quiet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Speech intelligibility in noise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
VRB (Vocale Rapide dans le Bruit)
Other Intervention Name(s)
french Quick SIN
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction questionnaire
Description
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
Secondary Outcome Measure Information:
Title
Speech comprehension in quiet
Description
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
Title
Speech comprehension in Noise
Description
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
Title
French Quick Sin
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Vincent, MD, PROF
Organizational Affiliation
Hôpital Roger Salengro CHRU de Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Hôpital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
CHRU de Nancy Hôpital central
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
CHU de Nantes Hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
CHU Nice - Institut Universitaire de la Face et du Cou
City
Nice
ZIP/Postal Code
06103
Country
France
Facility Name
Hôpitaux Pédiatriques de Nice CHU-Lenval
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Hôpital Pitié Salpêtrière - APHP
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

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