Speech Perception Assessment via Mobile App for Hearing Loss

(VALDE-MU Trial)

Recruiting at 2 trial locations

Overseen By Geert De Ceulaer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cochlear

Disqualifiers: Pregnancy, Other trial participation, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Varies

46 Participants Needed

Trial Summary

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 is best to discuss this with the trial investigator.

What data supports the effectiveness of the treatment Mobile Research App, Mobile Research App, Cochlear CoPilot for hearing loss?

Research shows that smartphone-based apps can improve speech recognition in noisy environments for people with hearing impairments, as seen with the SHARP-2 app, which enhanced hearing aid performance. This suggests that similar mobile apps, like the Mobile Research App and Cochlear CoPilot, could also be effective in helping people with hearing loss. ^{1 2 3 4 5}

Is the Mobile Research App safe for use in humans?

The research on cochlear implant and hearing aid technology includes a study that proposes a framework for evaluating the safety and reliability of research platforms, which could be relevant for assessing the safety of the Mobile Research App. ^{1 6 7 8 9}

How does the Mobile Research App treatment for hearing loss differ from other treatments?

The Mobile Research App, also known as Cochlear CoPilot, is unique because it uses a smartphone-based app to enhance speech recognition in noisy environments, providing an economical and accessible solution for people with hearing loss. Unlike traditional hearing aids or cochlear implants that require clinical settings for adjustments, this app allows users to assess and improve their hearing performance at home, making it a convenient and flexible option. ^{3 10 11 12 13}

What is the purpose of this trial?

The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.

Eligibility Criteria

This trial is for adults over 18 who use a hearing device, are fluent in the language of the speech perception test, and can consent to participate. It's not for Cochlear employees, those involved in other drug/device trials within 30 days, or pregnant women.

Inclusion Criteria

Uses a hearing device or devices (hearing aid/s and/or cochlear implant/s)

Fluent speaker in the language used to assess clinical performance as judged by the investigator

Willing and able to provide written informed consent

Exclusion Criteria

Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator

Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation)

Employees of Cochlear or companies working with Cochlear on this research cannot participate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Participants use the Mobile Research App to measure and validate speech perception endpoints

Varies

In-clinic and at home visits

Follow-up

Participants are monitored for speech perception ability and test-retest reliability

4 weeks

Treatment Details

Interventions

• Mobile Research App

Trial Overview The study tests a Mobile Research App designed to measure speech perception in adult cochlear implant users. It's an international feasibility study comparing app results with standard-of-care methods.

Participant Groups

Group I: Delivery of speech perception materials in-clinic using the Mobile Research App (MRA) Experimental Treatment 2 Interventions

Cochlear implant recipients will participate in this arm (sub-investigation AI5841A).

Group II: Delivery of speech perception materials in-clinic and at home using the Mobile Research App (MRA) Experimental Treatment 2 Interventions

Cochlear implant and hearing aid recipients will participate in this arm (sub-investigation AI5841B).

Mobile Research App is already approved in United States, Canada for the following indications:

Approved in United States as Cochlear CoPilot for:

• Speech perception assessment for adult cochlear implant recipients

Approved in Canada as Cochlear CoPilot for:

• Speech perception assessment for adult cochlear implant recipients

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

Findings from Research

A new smartphone application allows cochlear implant users to self-select frequency allocation tables (FATs) in real time, potentially enhancing their sound quality and speech perception.

In a pilot study with six cochlear implant subjects, all participants preferred a different FAT than the standard one, and their speech perception scores using the self-selected FAT were comparable to those with the clinical FAT, indicating the app's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone Application for Customized Frequency Table Selection in Cochlear Implants. Jethanamest, D., Azadpour, M., Zeman, AM., et al.[2019]

The AMTASTM PC-based audiometry and a low-cost smartphone audiometry app (R-App) demonstrated accuracy comparable to traditional manual audiometry, with mean threshold differences within ±1.5 dB for AMTASTM and ±1 dB for the R-App across tested frequencies (250-8000 Hz).

Both user-operated methods showed good test-retest reliability, with acceptable variations in results, indicating they can be effectively used in non-soundproofed environments for hearing assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AMTASTM and user-operated smartphone research application audiometry-An evaluation study. Sørensen, CB., Adams, TB., Pedersen, ER., et al.[2023]

The SHARP-2 app significantly improved speech recognition in noise for both individuals with normal hearing (33.56% improvement) and those with impaired hearing (22.21%) when used with compatible hearing aids.

The study involved participants using three different sets of hearing aids connected to an iPhone, demonstrating that smartphone-based apps can be an effective and cost-efficient solution for enhancing hearing in challenging listening environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Validation of the Smartphone for Remote Microphone Technology. Tittle, S., Thibodeau, LM., Panahi, I., et al.[2021]

The study involved 32 patients with hearing loss, comparing results from a smartphone app to conventional audiometry, showing a significant agreement between the two methods (p < 0.05).

The mobile app, Ear Trumpet version 1.0.2, demonstrated reliable results in measuring hearing loss, indicating it could be a useful tool for initial audiological evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial assessment of hearing loss using a mobile application for audiological evaluation. Derin, S., Cam, OH., Beydilli, H., et al.[2019]

The smartphone audiogram application, Mimi™, showed a moderate correlation with standard audiometric testing, with correlation coefficients ranging from 0.51 to 0.68, indicating it can be a useful tool for assessing hearing thresholds in adults.

The app demonstrated high specificity (97.1%) for normal hearing and good sensitivity (80%) for severe hearing loss, suggesting it is particularly effective at identifying severe cases, although its overall sensitivity for detecting hearing loss was lower at 35.5%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pure tone audiometry as assessed by a commercially-available mobile phone application compared to formal audiometry. Davis, L., Hwa, TP., Eliades, SJ., et al.[2022]

This study introduces a new evaluation protocol for research platforms (RPs) used in cochlear implants (CIs) and hearing aids (HAs) to ensure their operational safety and reliability, which is crucial for advancing hearing restoration technologies.

The proposed two-phase analysis includes an acoustic phase to assess sound output safety and a parameter phase to evaluate the reliability of electrical stimulation, providing a structured approach to improve the design and testing of hearing devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation framework for research platforms to advance cochlear implant/hearing aid technology: A case study with CCi-MOBILE. Shekar, RCMC., Hansen, JHL.[2022]

A study of 594 cochlear implant users revealed that 20% of adults and over 40% of children had a history of otitis media, which may negatively impact cochlear implant outcomes.

The research highlights the importance of accurate and consistent recording of patient data, particularly regarding factors like middle ear inflammation, to enhance data science efforts aimed at improving cochlear implant effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging real-world data to improve cochlear implant outcomes: Is the data available? Findlay, C., Edwards, M., Hough, K., et al.[2023]

In a study of 75 patients undergoing cochlear implantation, 39% experienced dizziness post-surgery, with most reporting delayed episodic vertigo that began a median of 74 days after the procedure.

Preoperative dizziness, older age at implantation, and earlier onset of hearing loss were significant risk factors for developing post-implantation dizziness, suggesting that these factors may influence vestibular symptoms after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular dysfunction after cochlear implantation. Fina, M., Skinner, M., Goebel, JA., et al.[2022]

A new pediatric hearing loss database has been successfully established, including data from over 2,900 children, which enhances scientific data collection and clinical workflow in managing hearing loss and cochlear implants.

The database has shown that speech perception performance improves with age and longer use of cochlear implants, providing valuable insights for future clinical studies and patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An online database to improve clinical operations and scientific data collection in a pediatric hearing loss practice. Formeister, EJ., Forgues, M., Adunka, OF.[2018]

The NIH Toolbox® Hearing Threshold Test (HTT) is a validated tablet-based hearing assessment that can accurately estimate hearing sensitivity in both children and adults, showing a strong correlation with traditional clinical assessments (r = .83-.93).

The HTT meets clinical reliability standards, making it a practical alternative for evaluating hearing acuity without the need for professional audiologists or specialized equipment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a tablet-based assessment of auditory sensitivity for researchers. Wiseman, K., Slotkin, J., Spratford, M., et al.[2023]

Cochlear implant recipients demonstrated significantly improved speech perception after surgery, with mean scores of 88.6% for recorded speech and 92.3% for live voice, compared to only 37.2% preoperatively.

Mobile phones provided better speech perception scores (84.3%) than standard landlines (57%), suggesting that cochlear implant users may have a more effective experience using mobile devices for communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile and landline telephone performance outcomes among telephone-using cochlear implant recipients. Tan, BY., Gluth, MB., Statham, EL., et al.[2014]

The CCi-MOBILE platform is an innovative, open-source tool designed to enhance hearing research by allowing complex signal processing for cochlear implants and hearing aids, addressing the limitations of current clinical technologies.

This platform enables researchers to conduct a wide range of listening experiments in various environments, including quiet and noisy conditions, using portable devices like smartphones and tablets, which improves accessibility and flexibility in hearing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CCi-MOBILE: Design and Evaluation of a Cochlear Implant and Hearing Aid Research Platform for Speech Scientists and Engineers. Hansen, JHL., Ali, H., Saba, JN., et al.[2023]

Home-based speech perception testing using digit recognition in noise (DiN) is a reliable alternative to traditional clinic-based sentence recognition in noise (SiN) assessments for cochlear implant users, showing similar performance outcomes.

Phoneme identification tasks conducted at home provide valuable insights into speech perception and can help personalize rehabilitation by tracking performance changes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Speech Perception Monitoring for Clinical Use With Cochlear Implant Users. van Wieringen, A., Magits, S., Francart, T., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Smartphone Application for Customized Frequency Table Selection in Cochlear Implants. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

AMTASTM and user-operated smartphone research application audiometry-An evaluation study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral Validation of the Smartphone for Remote Microphone Technology. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Initial assessment of hearing loss using a mobile application for audiological evaluation. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Pure tone audiometry as assessed by a commercially-available mobile phone application compared to formal audiometry. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

An evaluation framework for research platforms to advance cochlear implant/hearing aid technology: A case study with CCi-MOBILE. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Leveraging real-world data to improve cochlear implant outcomes: Is the data available? [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Vestibular dysfunction after cochlear implantation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

An online database to improve clinical operations and scientific data collection in a pediatric hearing loss practice. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Validation of a tablet-based assessment of auditory sensitivity for researchers. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Mobile and landline telephone performance outcomes among telephone-using cochlear implant recipients. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

CCi-MOBILE: Design and Evaluation of a Cochlear Implant and Hearing Aid Research Platform for Speech Scientists and Engineers. [2023]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Home-Based Speech Perception Monitoring for Clinical Use With Cochlear Implant Users. [2021]