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Hearing Outcomes With the Nucleus® 8 Sound Processor and Nucleus® 7 Sound Processor in Adult Veteran and Non-veteran Cochlear Implant Recipients (SALUTE)

6 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

26

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Colorado
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Denver Research and Technology Lab
        • Contato:
          • PRS Specialist

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Inclusion Criteria:

  1. Aged 18 years or older, at time of consent.
  2. 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.
  3. At least 18 active electrodes in the test ear.
  4. At least 6 months experience with a cochlear implant in the test ear.
  5. Able to score 20% or more at +10 dB SNR with CI alone on an S0N0 sentence in-noise test in the test ear.
  6. Pure-tone average unaided threshold (500 through 4000 Hz) ≥ 30 dB HL, in the contralateral ear.
  7. Candidate is a fluent speaker in the language used to assess speech perception performance.
  8. Direct access to a compatible smartphone.
  9. Willing and able to provide written informed consent.

Exclusion Criteria:

  1. Recipients with single-sided deafness as determined by the Investigator.
  2. Additional disabilities that would prevent participation in evaluations.
  3. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedures.
  4. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
  5. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
  6. Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation.
  7. 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).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Veterans
Dispositivo: Nucleus 7 Sound Processor
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).
Dispositivo: Nucleus 8 Sound Processor
Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.
Experimental: Non-veterans
Dispositivo: Nucleus 7 Sound Processor
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).
Dispositivo: Nucleus 8 Sound Processor
Nucleus 8 Sound Processor will be used with the SCAN 2 ForwardFocus (SCAN 2 FF) program to evaluate speech performance.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Week 2 and week 4
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.
Week 2 and week 4
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
Prazo: 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
Prazo: 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
Proportion of participants preferring each sound processor in various listening domains
Prazo: Week 4
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".
Week 4
Mean difference in SSQ-12 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
Prazo: Week 2 and Week 4
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.
Week 2 and Week 4
Mean difference in VFS-A-10 total scores between the Nucleus 8 Sound Processor and the Nucleus 7 Sound Processor
Prazo: Week 2 and Week 4
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).
Week 2 and Week 4

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cochlear

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de setembro de 2026

Conclusão do estudo (Estimado)

1 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

6 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de maio de 2026

Primeira postagem (Real)

12 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CAM02835

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Sim

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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