Electrical Loudness Scaling for Hearing Loss

(ELSA Trial)

Recruiting at 2 trial locations

Overseen By Anke Plasmans

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Visual impairment, Dexterity issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new feature for programming cochlear implants, devices that help people with severe hearing loss hear better. The focus is on "Fast Electrical Categorical Loudness Scaling," a task that lets users adjust their implant settings using a mobile app. This feature could make the process quicker and easier for users. The trial seeks individuals who have used a specific type of cochlear implant for at least three months and can adjust to new settings independently. Participants will try the new feature, take part in hearing tests, and share their experiences. As an unphased trial, this study offers a unique opportunity to contribute to innovative technology that could enhance the cochlear implant user experience.

Will I have to stop taking my current medications?

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 the Electrical Loudness Scaling task is safe for cochlear implant users?

Previous studies have shown promise for the "Electrical Loudness Scaling" task from the Nexus Research System for home use. Research demonstrated that it delivers accurate sound levels and effectively manages background noise at home. This suggests the task is safe and reliable for users. These studies reported no significant negative effects. Designed for cochlear implant users, this feature helps them adjust to sound levels and appears to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Electrical Loudness Scaling (ELS) task for hearing loss because it introduces a new way to assess and potentially manage this condition. Unlike current treatments, which often focus on hearing aids or cochlear implants to amplify sound, the ELS task uses a fast, electrical method to measure how individuals perceive sound loudness. This approach could provide more precise insights into a patient's hearing profile, leading to more personalized treatment plans. By understanding loudness perception more accurately, researchers hope to enhance the effectiveness of existing therapies and improve quality of life for those with hearing loss.

What evidence suggests that the Electrical Loudness Scaling task is effective for hearing loss?

Research has shown that the Fast Electrical Categorical Loudness Scaling (ELS) task helps people with cochlear implants measure sound levels more easily. In this trial, participants will receive both the Standard and Fast ELS tasks. Studies have found that this method allows users to accurately measure loudness at home while controlling background noise. This enables them to adjust their implants more effectively without frequent clinic visits. The updated feature speeds up data collection and improves user feedback. Overall, these improvements provide a more user-friendly way to manage hearing levels. ^{1 2 3 6 7}

Who Is on the Research Team?

Anke Plasmans

Principal Investigator

Cochlear Limited

Are You a Good Fit for This Trial?

This trial is for adults who have experience using cochlear implants due to sensorineural hearing loss. Participants should be familiar with their device and able to provide feedback on a new feature that's tested through a mobile app.

Inclusion Criteria

At least three months of experience with the cochlear implant

Implanted with the CI600 series (CI612, CI622, CI632) or CI500 series (CI512, CI522, CI532) cochlear implant

Able to be programmed with ACE (Advanced Combination Encoder), a fixed pulse width (PW) MAP with a maximum PW of 50 us per channel and with ≥ 18 enabled channels on the sound processor MAP

Exclusion Criteria

Additional health factors, known to the investigator, that would prevent or restrict participation in the evaluations, including significant visual impairment and/or dexterity issues

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Nexus Research System for cochlear implant programming, including Electrical Loudness Scaling tasks both on-site and at home

2 weeks

Multiple sessions on-site and at home

Follow-up

Participants are monitored for feedback on the updated feature and test-retest reliability of Fast-ELS outcomes

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fast Electrical Categorical Loudness Scaling task

Trial Overview The study tests two ways of adjusting cochlear implants: the Standard Electrical Categorical Loudness Scaling (Standard-ELS) and an updated, faster version (Fast-ELS), both part of the Nexus Research System used in MAP fitting.

How Is the Trial Designed?

Group I: Experimental: Participants receiving both Standard and Fast ELS task Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Cochlear

Lead Sponsor

Trials

96

Recruited

6,300+

Headquarters

Sydney, Australia

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07077070

Study Details | NCT07077070 | Investigating Electrical ... This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07077070?term=AREA%5BConditionSearch%5D(%22Hearing%20Loss,%20Sensorineural%22)&rank=3

Investigating Electrical Categorical Loudness Scaling ... This clinical study will evaluate a feature of the investigational Nexus Research System used for programming cochlear implants.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9128724/

Evaluation of Remote Categorical Loudness Scaling - PMC This study demonstrated that precise stimulus levels can be delivered and background noise levels can be controlled in a home environment.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S037859551400121X

Optimized loudness-function estimation for categorical ... The goal of this study was to investigate different methods of loudness-function estimation from CLS data in terms of their test–retest behaviour and to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4417023/

Categorical loudness scaling and equal-loudness contours ... This study describes procedures for constructing equal-loudness contours (ELCs) in units of phons from categorical loudness scaling (CLS) data

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3376894/

Reliability of Categorical Loudness Scaling and its Relation to ... CLS functions were obtained on 74 subjects, 58 with hearing loss and 16 with normal hearing. CLS functions were measured at three frequencies (1, 2, and 4 kHz) ...

7. bibliotekanauki.pl bibliotekanauki.pl/articles/178032.pdf

Loudness Scaling Test Based on Categorical Perception The main goal of this research study is focused on creating a method for loudness scaling based on categorical perception. Its main features, such as: way ...