Cochlear Implant Fitting Methods for Hearing Loss

(CALOS4 Trial)

No longer recruiting at 5 trial locations

Overseen By Anke Plasmans

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Auditory neuropathy, Visual impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to fine-tune cochlear implants for individuals who lost their hearing after learning to speak. It compares two fitting methods—behavioral fitting and categorical loudness scaling-based fitting—to determine which one enhances hearing and comfort. Individuals with a cochlear implant who experienced severe hearing loss after age two may qualify. Participants will try both fitting methods over several weeks, aiding researchers in improving future cochlear implant programming. As an unphased trial, this study allows participants to contribute to advancements in cochlear implant technology and improve outcomes for future users.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these cochlear implant fitting methods are safe?

Research shows that cochlear implants, which assist people with severe hearing loss, are generally safe. The Categorical Loudness Scaling method adjusts the implant by providing information about perceived sound loudness. Studies have not reported specific negative effects from this method.

For the Behavioural Fitting method, research indicates that cochlear implants are safe and effective. Most side effects from cochlear implant surgeries are minor and temporary. People typically adjust well to the device, enhancing their hearing and quality of life.

Overall, both methods for adjusting cochlear implants are well-tolerated and considered safe based on available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for cochlear implant fitting methods because it explores innovative ways to enhance hearing outcomes for people with hearing loss. Unlike standard fitting techniques, which might not always perfectly match individual needs, this trial examines both behavioral fitting and categorical loudness scaling-based fitting. These methods aim to tailor the cochlear implant experience more precisely to each user, potentially leading to better sound perception and overall satisfaction. By offering a personalized approach, this trial could pave the way for more effective and user-friendly hearing solutions.

What evidence suggests that these cochlear implant fitting methods are effective for hearing loss?

Research has shown that two methods, categorical loudness scaling and behavioral fitting, are promising for effectively setting up cochlear implants. In this trial, participants will receive both categorical loudness scaling-based fitting and behavioral fitting. Categorical loudness scaling reliably provides consistent loudness levels across different sessions. This method adjusts implant settings based on user comfort, potentially improving hearing. Behavioral fitting enhances speech understanding and quality of life, particularly for older adults and children with cochlear implants. Both methods aim to improve hearing and quality of life by customizing implant settings to fit individual needs. ^{6 7 8 9 10}

Who Is on the Research Team?

Anke Plasmans

Principal Investigator

Cochlear

Are You a Good Fit for This Trial?

This trial is for adults over 18 who became deaf after age 2 and now have a CI600 or CI500 series cochlear implant. Participants must understand the language used in speech tests and agree to follow the study rules.

Inclusion Criteria

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

Willingness to participate in and comply with all requirements of the protocol

Willing and able to provide written informed consent

Exclusion Criteria

Subject who will be programmed with an acoustic component in the implanted ear

Pure tone average (average of unaided thresholds at 0.5, 1, 2 and 4 kHz) less than or equal to 30 dB HL and aided word score of more than 80% in the contralateral ear

Score below 3 on the screening subset of questions from the Mobile Device Proficiency Questionnaire

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive both Categorical Loudness Scaling Based Fitting and Behavioural Fitting with 4 weeks experience of both MAPS

4 weeks

Multiple visits for fitting and testing

Follow-up

Participants are monitored for performance outcomes and further refinement of fitting methods

4 weeks

Follow-up visits for outcome measures

What Are the Treatments Tested in This Trial?

Interventions

• Behavioural fitting
• Categorical loudness scaling based fitting

Trial Overview The study compares two ways of setting up cochlear implants: one uses behavioral fitting with Custom Sound Suite software, and the other uses loudness scaling with Nexus System. It's to find out which method works best post-activation.

How Is the Trial Designed?

Group I: Participants receiving both Categorical Loudness Scaling Based Fitting and behavioural fitting. Experimental Treatment 2 Interventions

Participants will receive a categorical loudness scaling based fitting (Interventional) and behavioural fitting with 4 weeks experience of both MAPS

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

QbD Clinical

Industry Sponsor

Trials

5

Recruited

400+

QbD Clinical

Collaborator

Trials

6

Recruited

460+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Published Research Related to This Trial

Cochlear implants (CIs) effectively restore hearing in individuals with total sensorineural hearing loss by converting sound into electrical signals for the auditory nerve, but the current fitting process is often generic and may not optimize individual user outcomes.

To improve speech recognition variability among CI users, the authors propose using objective, patient-specific data and machine-learning algorithms to create personalized fitting procedures that account for individual differences in auditory system function and electrode activation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards personalized and optimized fitting of cochlear implants. Van Opstal, AJ., Noordanus, E.[2023]

The study involved 10 profoundly hearing impaired children aged 2 to 7 years, and it demonstrated that multi-modal electrophysiological tests can effectively predict optimal comfort levels (M-Levels) for cochlear implant programming, especially in challenging cases where behavioral responses are hard to obtain.

Significant positive correlations were found between electrophysiological thresholds and behavioral comfort levels over the first year of implant use, indicating that this statistical method can reliably assist audiologists in creating effective cochlear implant maps (MAPs) when direct behavioral measurements are difficult.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological Correlates of Behavioral Comfort Levels in Cochlear Implantees: A Prospective Study. Raghunandhan, S., Ravikumar, A., Kameswaran, M., et al.[2020]

The study involving six Nucleus-22 cochlear implant users found that the relationship between loudness and electrical stimulation varies significantly among individuals, indicating a need for personalized mapping of acoustic amplitudes to electric currents.

Loudness growth was influenced by stimulation rate and electrode configuration, with some subjects showing nonlinear loudness responses at lower stimulation rates, suggesting that low-frequency stimulation may be processed differently across electrode locations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Loudness growth in cochlear implants: effect of stimulation rate and electrode configuration. Fu, QJ.[2007]

The study involved 10 profoundly hearing impaired children aged 2 to 7 years, and it found that multi-modal electrophysiological tests (like NRI, ESRT, and EABR) showed significant positive correlations with behavioral comfort levels (M-levels) over the first year of cochlear implant use.

Predictive formulae derived from these correlations can help audiologists set initial MAPs in 'difficult to MAP' cases, but individual variability means that behavioral measures are still essential for optimizing these settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical study of electrophysiological correlates of behavioural comfort levels in cochlear implantees. Raghunandhan, S., Ravikumar, A., Kameswaran, M., et al.[2014]

The analysis of 39,885 MAPs from 47 cochlear implant recipients revealed distinct comfort level profiles for different electrode arrays, indicating the need for tailored fitting approaches.

The new Custom Sound Pro fitting software allows clinicians to efficiently create accurate comfort level profiles with just nine Neural Response Telemetry thresholds, while 99% of clinical tasks were completed successfully on the first use, enhancing both usability and patient-centered care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Custom Sound® Pro software utilising big data and its clinical evaluation. Maruthurkkara, S., Bennett, C.[2023]

Cochlear implant recipients were able to categorize loudness levels of electric and acoustic stimuli, helping to establish a normal loudness perception across the dynamic range of sounds.

The study suggests that individual mapping functions for cochlear implants may need to be flexible and specific to each channel to optimize loudness perception, as one mapping function may not work for all channels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indication for the need of flexible and frequency specific mapping functions in cochlear implant speech processors. Hoth, S.[2018]

Cochlear implant fitting has evolved to include objective electrophysiologic measures and expert knowledge, moving away from solely relying on behavioral responses, which enhances the accuracy of the fitting process.

Recent advancements aim to automate and streamline the fitting process, reducing the time needed for adjustments and allowing for real-time testing of settings, ultimately improving the quality of hearing and speech comprehension for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cochlear implant fitting strategies]. Hoppe, U., Liebscher, T., Hornung, J.[2019]

The study examined the relationship between current levels for cochlear implant sound processor fitting and compound action potential thresholds measured by Neural Response Telemetry (NRT), finding that the correlation between NRT and behavioral measures is weak due to individual variability among implantees.

A proposed model suggested that measuring the effect of interphase gap on NRT amplitude could improve the predictability of NRT thresholds, but this hypothesis was not supported in a small experimental group of eight subjects, indicating the need for further research to enhance the utility of NRT in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A different approach to using neural response telemetry for automated cochlear implant processor programming. McKay, CM., Fewster, L., Dawson, P.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9536882/

and Post-Cochlear Implant: An Egyptian Study The present study aimed to detect the behavioral problems pre- and post-cochlear implantation in comparison to normal hearing group to be able to manage these ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0165027020302259

A behavioral method to estimate charge integration ... The present method offers a quick behavioral test with which to measure charge integration efficiency, which may be a useful measure of neural health.

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Hearing and Quality-of-Life Outcomes After Cochlear ... Older adults in this study achieved clinically meaningful improvement in both speech perception and patient-reported quality-of-life metrics ...

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Cochlear Implant Behavioral Outcomes for Children With ... Improvements in outcome performance were observed in all the included studies. Children with ANSD fit with CIs can achieve outcomes similar to children with ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/14670100.2024.2382579

Factors impacting outcomes of cochlear implantation in ... Data were from 288 children with a mean age at implant of 2.74 years. Overall follow-up at 1 year was 59% and 51% at 2 years. Younger age at ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED) It is recommended that prior to cochlear implantation, individuals with SSD have at least two (2) weeks to one (1) month experience wearing ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11843266/

Evaluation of Safety and Effectiveness of the LISTENT LCI ... Cochlear implantation is safe and effective in restoring hearing and speech recognition abilities for individuals with severe to profound sensorineural hearing ...

8. mdpi.com mdpi.com/2075-4426/12/8/1326

Long-Term Device Satisfaction and Safety after Cochlear ... This study found significant relationships between daily device use and FG, wearing comfort and long-term safety (90 months).

9. sciencedirect.com sciencedirect.com/science/article/pii/S1808869424001277

Brazilian Society of Otology task force – cochlear implant ... CI is a safe device for auditory rehabilitation of patients with severe-to-profound hearing loss. In recent years, indications for unilateral hearing loss and ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7453343/

Hearing and Quality-of-Life Outcomes After Cochlear ... The implant surgery was generally well tolerated, with most adverse events being minor, temporary, and commonly associated with a cochlear ...