Skip to main content
OpenTrials
Completed

NCT Number: NCT03674086

Evaluation of the eAdjust Application

Despite being effective, the majority of people who would benefit from using hearing aids do not access them. For those who do obtain hearing aids, around 20% do not wear them regularly. People often do not use their hearing aids because they continue to experience difficulties when listening to and understanding speech in noisy situations.

Conventional hearing aids must be programmed and adjusted by a trained audiologist with specialist equipment and therefore provide limited user-control over the hearing aid's functionality. In comparison to conventional hearing aids, Smartphone-connected hearing aids enable patients to adjust their programmes themselves in different situations using a Smartphone application. Smartphone-connectivity can supplement clinical practices, as patients can adjust their hearing aids without the need to visit the clinic. This has the potential to empower patients to be actively involved in their own hearing healthcare.

A systematic review assessing the effectiveness of alternative listening devices showed that there is no published high-quality research assessing the clinical effectiveness of Smartphone-connected hearing aids. Furthermore, a usability research study has shown that patients want to personalise and adjust their own HA programmes to meet their individual needs. Having carried out the early development work, the next step would be to carry out a study to evaluate smartphone-connected hearing aids, in accordance with the MRC guidelines on developing and evaluating complex interventions.

This study will assess the benefits of a smartphone application, eAdjust that has been developed for use with Phonak Audeo B90-Direct hearing aids. The eAdjust app connects to the hearing aid via Bluetooth, and enables hearing aid users to fine-tune their hearing aids via their smartphone. The benefits of the eAdjust app will be assessed in the real-world as well as in the laboratory. A mixed methods approach will be taken, using both behavioural and patient reported outcomes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hearing Loss, Bilateral Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute for Health Research Nottingham Biomedical Research Centre

Nottingham, Non-US/Non-Canadian, NG1 5DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged ≥18 years.
  • With hearing loss type: symmetric (not more than 20 dB difference) and sensorineural.
  • With mild to severe hearing loss in the categories: N2, N3, N4, N5, S2 and S3.
  • No disturbing tinnitus.
  • No contraindications against wearing hearing aids (e.g. ear disease or motor impairment).
  • Hearing aid user:
  • First-time (using hearing aids < 3 months)
  • Existing (using hearing aids > 6 months)
  • Owns an iPhone (v5 and IOS 10 or higher) and uses functions of her/his smartphone which exceed calling and writing text messages.
  • Willing to wear test hearing aids, to use the eAdjust App, to take notes about experiences and to perform various tasks during the study period.
  • English as a first spoken language or a good understanding of English. It is important that participants can understand the content of the resources and work with the interactive elements, as well as be able to answer outcome questionnaires, to ensure valid data are collected.

Exclusion criteria

  • Unable to complete the questionnaires without assistance due to age-related problems (e.g. cognitive decline or dementia), to ensure valid data are collected.

Treatment and study plan

eAdjust 0.2 hearing aid smartphone application (or app)

Device

The app connects to the Audeo B-90 Direct hearing aids via Bluetooth. The intended use for the app to enable hearing aid users to fine-tune their hearing aids. The app contains a series of sound modifiers, factory presets, sound modifier presets.

Primary outcomes

  1. Hearing Handicap Inventory for the Elderly

    Time frame: Change from Baseline following 7-weeks of intervention use.

    25-item self-reported questionnaire assessing the effects of hearing loss on the emotional and social/situational adjustment. Scored using a three-point scale.

Secondary outcomes

  1. Glasgow Hearing Aid Benefit Profile

    Time frame: Baseline (Part I) and following 7-weeks of intervention use (Part II).

    Assesses self-reported hearing disability and handicap (Part I), as well as hearing aid use, benefit, residual disability and satisfaction (Part II). Each domain is measured on a five-point scale.

  2. Vanderbilt Fatigue Scale for Adults with Hearing Loss

    Time frame: Change from Baseline following 7-weeks of intervention use.

    A 40-item self-report measure of listening effort and fatigue. Scored using a five-point scale.

  3. Device-Orientated Subjective Outcome scale

    Time frame: Change from Baseline following 7-weeks of intervention use.

    Self-report questionnaire suitable for quantifying subjective hearing aid outcomes. Scored using a seven-point response scale.

  4. Glasgow Hearing Aid Difference Profile (existing hearing aid users only)

    Time frame: Change from Baseline following 7-weeks of intervention use.

    Assesses self-reported use and residual disability with 'old' hearing aids (Part I), as well as use and residual disability with 'new' hearing aids, and the difference in benefit and and satisfaction between 'old and 'new' hearing aids (Part II). Each domain is measured on a five-point scale.

  5. Auditory Lifestyle and Demands Questionnaire

    Time frame: Following 1-week of intervention use.

    Self-report measure of auditory lifestyle.

  6. Clarity and Comfort Questionnaire

    Time frame: Following 1-week of intervention use.

    Self-report measure of hearing aid preferences concerning sound clarity and comfort.

  7. Hearing aid datalogging

    Time frame: Following 1-week and 7-weeks of intervention use.

    Hearing aid use in hours, internal to the hearing aid.

  8. Montreal Cognitive Assessment

    Time frame: Following 1-week of intervention use.

    Validated screening tool for mild cognitive impairment.

  9. BKB Speeh-In-Noise Test

    Time frame: Following 1-week and 7-weeks of intervention use.

    Behavioural measure of speech intelligibility in the presence of background noise.

  10. eAdjust 0.2 app datalogging

    Time frame: Following 2-week and 6-weeks of intervention use.

    Usage data, internal to the app.

  11. App real-world use questionnaire

    Time frame: Following 2-week and 6-weeks of intervention use.

    Self-report questionnaire of app usage. Consists of closed- and open-ended questions.

  12. Hearing aid tasks

    Time frame: Following 2-week and 6-weeks of intervention use.

    Self-report questionnaire of app functionality in different environments.

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Collaborators

  • Sonova AG
  • University of Nottingham

Registry information

Official study title

Evaluation of the eAdjust Application to Provide Benefits in Users of Smartphone-connected Hearing Aids

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 17, 2018
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.