Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients (SALUTE)
6 mai 2026 mis à jour par: Cochlear
A Post-market Interventional, Prospective, Open-label, Multi-center, Clinical Investigation of Hearing Outcomes With the Nucleus 8 Sound Processor and Nucleus 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different sound processors: the Nucleus® 8 Sound Processor and the Nucleus® 7 Sound Processor, in adults with cochlear implants.
The study will include two groups of adult cochlear implant recipients: veterans and non-veterans. Comparing these groups will help researchers understand how these sound processors perform in veteran populations as well as the broader adult cochlear implant community.
Participants will use each sound processor and then take part in speech understanding tests in background noise. They will also complete questionnaires about their listening experiences with each processor.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
26
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: PRS Specialist
- Numéro de téléphone: +61294286555
- E-mail: cltd-prs-admin@cochlear.com
Lieux d'étude
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Colorado
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Lone Tree, Colorado, États-Unis, 80124
- Denver Research and Technology Lab
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Contact:
- PRS Specialist
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Aged 18 years or older, at time of consent.
- Implanted with the CI600 Series (CI612, CI632, CI622, CI624), CI500 Series (CI512, CI532, CI522) or Freedom Series (CI24R(CA), CI24R(ST) CI24R(CS), CI24M, CI24RE(CA), CI24RE(ST), CI422) in the test ear.
- At least 18 active electrodes in the test ear.
- At least 6 months experience with a cochlear implant in the test ear.
- Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.
- Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.
- Candidate is a fluent speaker in the language used to assess speech perception performance.
- Direct access to a compatible smartphone.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Recipients with single-sided deafness as determined by the Investigator.
- Additional disabilities that would prevent participation in evaluations.
- Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
- Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by Investigator or Sponsor to not impact this investigation).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Veterans
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While the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing.
This setting will be referred to as SCAN ForwardFocus (SCAN FF).
Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.
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Expérimental: Non-veterans
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While the user can turn ForwardFocus on from any program in the Nucleus 7 Sound Processor, for the duration of this study, SCAN will be used as the default program and ForwardFocus will be turned on for testing.
This setting will be referred to as SCAN ForwardFocus (SCAN FF).
Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N90 spatial configuration
Délai: Week 2 and week 4
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The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
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Week 2 and week 4
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S90N180 spatial configuration
Délai: Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N180 spatial configuration
Délai: Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in AzBio improvement (percentage-point change) for the Nucleus 8 Sound Processor (SCAN 2 FF minus SCAN 2) compared to the Nucleus 7 Sound Processor (SCAN FF minus SCAN) in the S0N180 spatial configuration
Délai: Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in CNC percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
Délai: Week 2 and week 4
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The consonant-nucleus-consonant (CNC) monosyllabic word test will be used to assess speech perception of words in quiet.
The test consists of 10 recorded lists of 50 monosyllabic words, produced by a male talker.
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Week 2 and week 4
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Paired difference in AzBio percent correct in quiet between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program in the S0 spatial configuration
Délai: Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
|
Paired difference in AzBio percent correct in noise between the Nucleus 8 Sound Processor using the SCAN 2 FF program and the Nucleus 7 Sound Processor using the SCAN FF program at a fixed signal-to-noise ratio in the S0N0 spatial configuration
Délai: Week 2 and week 4
|
The AzBio sentence test is a validated test used to assess open-set sentence recognition.
AzBio sentences are spoken in a conversational style with limited contextual cues that the listener can use to predict unintelligible words.
|
Week 2 and week 4
|
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Proportion of participants preferring each sound processor in various listening domains
Délai: Week 4
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The Device Preference Questionnaire is a custom self-assessment to evaluate participants' preference between the Nucleus 8 and Nucleus 7 Sound Processors, or "no preference".
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Week 4
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Mean difference in SSQ-12 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
Délai: Week 2 and Week 4
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The SSQ-12 is a validated 12-item abbreviated form of the Speech, Spatial, and Qualities of Hearing scale that measures self-reported hearing ability across speech, spatial, and sound quality domains, with each item rated from 0 (poor) to 10 (excellent).
Total scores are calculated by averaging responses across relevant items.
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Week 2 and Week 4
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Mean difference in VFS-A-10 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
Délai: Week 2 and Week 4
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The Vanderbilt Fatigue Scale-10-Item Adult (VFS-A-10) is a validated 10-item subjective scale designed to assess listening-related fatigue in adults with hearing loss.
The scale provides a total score based on all 10 questions rated on a Likert scale from 0 (no listening-related fatigue) to 4 (severe listening-related fatigue).
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Week 2 and Week 4
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 mai 2026
Achèvement primaire (Estimé)
1 septembre 2026
Achèvement de l'étude (Estimé)
1 septembre 2026
Dates d'inscription aux études
Première soumission
6 mai 2026
Première soumission répondant aux critères de contrôle qualité
6 mai 2026
Première publication (Réel)
12 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
12 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAM02835
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Cochlear do not have an approved platform for public sharing of IPD collected in this study.
Data may be provided to individual researchers on request.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .