Nucleus Sound Processors for Hearing Loss
(SALUTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a noise reduction feature called ForwardFocus with two sound processors: the Nucleus 7 Sound Processor and the Nucleus 8 Sound Processor, for individuals with cochlear implants. The main goal is to determine if these sound processors improve hearing in noisy environments for both veterans and non-veterans. Participants will use each processor, take speech tests in noisy settings, and share their listening experiences. Those with cochlear implants for at least six months who can use a smartphone might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance hearing technology for many.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that these sound processors are safe for adults with cochlear implants?
Research has shown that the Nucleus 7 Sound Processor is well-received by users and improves hearing in various settings. Its water-resistant design makes it suitable for everyday use without major issues.
The Nucleus 8 Sound Processor is easy to use and stands out as the smallest and lightest in its category. It is also water-resistant and has received FDA approval, indicating it has passed safety tests for human use.
Both sound processors are part of well-known cochlear implant systems and have demonstrated good safety in previous studies, making them generally safe for those needing hearing assistance.12345Why are researchers excited about this trial?
Researchers are excited about the Nucleus 7 and Nucleus 8 Sound Processors because they offer advanced technology that sets them apart from traditional hearing aids and cochlear implants. Unlike conventional options, these processors are designed to provide more precise sound quality and are equipped with wireless connectivity features, allowing for seamless integration with smartphones and other devices. Additionally, they offer personalized hearing experiences through customizable settings, which can significantly enhance the user's overall auditory experience. This innovation not only aims to improve hearing clarity but also to enhance the user's everyday interactions with their environment.
What evidence suggests that the ForwardFocus feature in the Nucleus Sound Processors is effective for hearing loss?
This trial will compare the Nucleus 7 Sound Processor and the Nucleus 8 Sound Processor for hearing loss. Studies have shown that the Nucleus 7 Sound Processor helps people hear better in various settings, especially noisy ones. Users find its features, such as mobile device connectivity, make everyday communication easier. Research on the Nucleus 8 Sound Processor suggests that its advanced technology, SmartSound iQ 2 with SCAN 2, improves hearing by about 8% in challenging listening situations. Many users express satisfaction with the Nucleus 8, particularly for hearing conversations in noisy environments. Both sound processors include a feature called ForwardFocus, which reduces background noise to make speech easier to hear. Overall, these devices aim to improve hearing quality for people with cochlear implants.15678
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have had a cochlear implant in one ear for at least 6 months, use certain implant models with at least 18 active electrodes, can understand speech tests in the study language, have some hearing in the other ear, and can use a compatible smartphone.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use each sound processor and take part in speech understanding tests in background noise, completing questionnaires about their listening experiences
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Nucleus 7 Sound Processor
- Nucleus 8 Sound Processor
Trial Overview
The study compares two sound processors—the Nucleus 8 and Nucleus 7—in adult cochlear implant users. Each participant will try both devices to see how well they help understand speech in noisy environments using a special noise reduction feature called ForwardFocus.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cochlear
Lead Sponsor
Dig Howitt
Cochlear
Chief Executive Officer since 2018
BE (Hons), MBA
Michael del Prado
Cochlear
Chief Medical Officer since 2022
MD, MSc, FRACP, FAAHMS, FAICD
Citations
A real-world evaluation of the clinical benefits of improved ...
The study demonstrated the benefits of the Nucleus 7 sound processor across different hearing environments in a Chinese population and showed improved hearing ...
Hearing Outcomes With the Nucleus® 8 Sound Processor ...
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different ...
Evaluating the Clinical- and Cost-Effectiveness of Cochlear ...
Participants reported that while older sound processors were better than hearing aids ... Nucleus® 7 Sound Processor with mobile connectivity. Cochlear Implant.
4.
mss-p-007-delivery.stylelabs.cloud
mss-p-007-delivery.stylelabs.cloud/api/public/content/FUN4714-Sound-Processor-Upgrades-Evidence-Summary.pdfSound Processor Upgrades Evidence Summary
With each successive generation of Nucleus® sound processors, hearing benefits are observed. Improved hearing performance, through features like ForwardFocus, ...
5.
ctv.veeva.com
ctv.veeva.com/study/hearing-outcomes-with-the-nucleus-r-8-sound-processor-and-nucleus-r-7-sound-processor-in-adult-veteranHearing Outcomes With the Nucleus® 8 Sound Processor and ...
The main purpose of this study is to understand how well a noise reduction feature called ForwardFocus works when used with two different ...
summary of safety and effectiveness data (ssed)
The Nucleus 24 cochlear implant system is intended for use in children 9 to 24 months of age who have bilateral profound sensorineural deafness and demonstrate ...
Introducing the Cochlear Nucleus® 7 Sound Processor
*** The Nucleus 7 Sound Processor with Aqua+ is water resistant to level IP68 of the International Standard IEC60529. This water protection ...
8.
mss-p-007-delivery.stylelabs.cloud
mss-p-007-delivery.stylelabs.cloud/api/public/content/cb9084073ff04088b2b3b4189e107b72?v=5b517e77Cochlear™Nucleus® cochlear implants
Safety data apply to all patients receiving a cochlear implant and are not specific to individuals with bilateral sensorineural hearing loss or single sided ...
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