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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 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

26

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Colorado
      • Lone Tree, Colorado, Stati Uniti, 80124
        • Denver Research and Technology Lab
        • Contatto:
          • PRS Specialist

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Cochlear

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 maggio 2026

Completamento primario (Stimato)

1 settembre 2026

Completamento dello studio (Stimato)

1 settembre 2026

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 aprile 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CAM02835

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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