Hearing Loss, BilateralNCT03674086

Evaluation of the eAdjust Application

An observational study of Hearing Loss, Bilateral and Hearing Loss, Sensorineural, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Hearing Loss, Bilateral, Hearing Loss, Sensorineural
What is being tested?: eAdjust 0.2 hearing aid smartphone application (or app)
Type of treatment: Medical device
How many people: 46 participants
Where: 1 siteUnited Kingdom
Study dates: 23 Aug 2018to 30 Apr 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Hearing aid users (first-time and existing) will be recruited from Nottingham Audiology Adult Service, Nottingham University Hospitals NHS Trust (secondary care). Immediately following the patient's hearing assessment appointment, a member of the patient's usual care team (audiologist) will identify eligible patients.

Who may be able to join

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:

Show all 11Show fewer

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

National Institute for Health Research Nottingham Biomedical Research Centre
Nottingham, Non-US/Non-Canadian, NG1 5DU

Other trials in United Kingdom

About this study

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

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.

Conditions: Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Being tested: eAdjust 0.2 hearing aid smartphone application (or app)
Medical subject headings: Hearing Loss, Bilateral, Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT03674086
Study group	Role	What they receive
First-time hearing aid user		Using hearing aids less than or equal to three months. Receives: Device: eAdjust 0.2 hearing aid smartphone application (or app)
Existing hearing aid user		Using hearing aids for 6 months or more. Receives: Device: eAdjust 0.2 hearing aid smartphone application (or app)

What is being measured

The primary outcome is the main question the study is designed to answer.

Hearing Handicap Inventory for the Elderly
25-item self-reported questionnaire assessing the effects of hearing loss on the emotional and social/situational adjustment. Scored using a three-point scale.
Measured: Change from Baseline following 7-weeks of intervention use.

Secondary outcomes (12)

Glasgow Hearing Aid Benefit Profile
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.
Measured: Baseline (Part I) and following 7-weeks of intervention use (Part II).
Vanderbilt Fatigue Scale for Adults with Hearing Loss
A 40-item self-report measure of listening effort and fatigue. Scored using a five-point scale.
Measured: Change from Baseline following 7-weeks of intervention use.
Device-Orientated Subjective Outcome scale
Self-report questionnaire suitable for quantifying subjective hearing aid outcomes. Scored using a seven-point response scale.
Measured: Change from Baseline following 7-weeks of intervention use.
Glasgow Hearing Aid Difference Profile (existing hearing aid users only)
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.
Measured: Change from Baseline following 7-weeks of intervention use.
Auditory Lifestyle and Demands Questionnaire
Self-report measure of auditory lifestyle.
Measured: Following 1-week of intervention use.
Clarity and Comfort Questionnaire
Self-report measure of hearing aid preferences concerning sound clarity and comfort.
Measured: Following 1-week of intervention use.
Hearing aid datalogging
Hearing aid use in hours, internal to the hearing aid.
Measured: Following 1-week and 7-weeks of intervention use.
Montreal Cognitive Assessment
Validated screening tool for mild cognitive impairment.
Measured: Following 1-week of intervention use.
BKB Speeh-In-Noise Test
Behavioural measure of speech intelligibility in the presence of background noise.
Measured: Following 1-week and 7-weeks of intervention use.
eAdjust 0.2 app datalogging
Usage data, internal to the app.
Measured: Following 2-week and 6-weeks of intervention use.
App real-world use questionnaire
Self-report questionnaire of app usage. Consists of closed- and open-ended questions.
Measured: Following 2-week and 6-weeks of intervention use.
Hearing aid tasks
Self-report questionnaire of app functionality in different environments.
Measured: Following 2-week and 6-weeks of intervention use.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 201830 Apr 2019

First posted17 Sep 2018
Study start23 Aug 2018
Primary completion14 Dec 2018
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hearing Loss, BilateralStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03674086
Sponsor's protocol ID: 18IH002
Status last verified: Mar 2019
First submitted: 13 Sep 2018
Last updated: 19 Feb 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Gomez R, Habib A, Maidment DW, Ferguson MA. Smartphone-Connected Hearing Aids Enable and Empower Self-Management of Hearing Loss: A Qualitative Interview Study Underpinned by the Behavior Change Wheel. Ear Hear. 2022 May/Jun;43(3):921-932. doi: 10.1097/AUD.0000000000001143.
PubMed 34653030

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hearing Loss, Bilateral trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the eAdjust Application to Provide Benefits in Users of Smartphone-connected Hearing Aids
ClinicalTrials.gov ID: NCT03674086
Acronym / sponsor ID: 18IH002
Conditions: Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Study type: Observational
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Nottingham University Hospitals NHS TrustUniversity, hospital or other
Collaborators: Sonova AG, University of Nottingham
Study start: 23 Aug 2018 (actual)
Primary completion: 14 Dec 2018 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 17 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
First-time hearing aid user	–	Device: eAdjust 0.2 hearing aid smartphone application (or app)Using hearing aids less than or equal to three months.
Existing hearing aid user	–	Device: eAdjust 0.2 hearing aid smartphone application (or app)Using hearing aids for 6 months or more.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Hearing aid users (first-time and existing) will be recruited from Nottingham Audiology Adult Service, Nottingham University Hospitals NHS Trust (secondary care). Immediately following the patient's hearing assessment appointment, a member of the patient's usual care team (audiologist) will identify eligible patients.

Key inclusion criteria (11 listed)

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).

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
eAdjust 0.2 hearing aid smartphone application (or app)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.	Device	Existing hearing aid user, First-time hearing aid user

Primary outcome

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.

12 secondary outcomes

Glasgow Hearing Aid Benefit Profile
Time frame: Baseline (Part I) and following 7-weeks of intervention use (Part II).
Vanderbilt Fatigue Scale for Adults with Hearing Loss
Time frame: Change from Baseline following 7-weeks of intervention use.
Device-Orientated Subjective Outcome scale
Time frame: Change from Baseline following 7-weeks of intervention use.
Glasgow Hearing Aid Difference Profile (existing hearing aid users only)
Time frame: Change from Baseline following 7-weeks of intervention use.
Auditory Lifestyle and Demands Questionnaire
Time frame: Following 1-week of intervention use.
Clarity and Comfort Questionnaire
Time frame: Following 1-week of intervention use.
Hearing aid datalogging
Time frame: Following 1-week and 7-weeks of intervention use.
Montreal Cognitive Assessment
Time frame: Following 1-week of intervention use.
BKB Speeh-In-Noise Test
Time frame: Following 1-week and 7-weeks of intervention use.
eAdjust 0.2 app datalogging
Time frame: Following 2-week and 6-weeks of intervention use.
App real-world use questionnaire
Time frame: Following 2-week and 6-weeks of intervention use.
Hearing aid tasks
Time frame: Following 2-week and 6-weeks of intervention use.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
Derived from this study: PubMed 34653030Gomez R, Habib A, Maidment DW, Ferguson MA. Smartphone-Connected Hearing Aids Enable and Empower Self-Management of Hearing Loss: A Qualitative Interview Study Underpinned by the Behavior Change Wheel. Ear Hear. 2022 May/Jun;43(3):921-932. doi: 10.1097/AUD.0000000000001143.
Individual participant dataSharing planned: Undecided

Related trials for Hearing Loss, Bilateral

Recruiting
Assessing Pharmacy Technician Educational Training for the Provision of Over-the-Counter Hearing Aids in Rural Alabama and Mississippi Pharmacies
Bilateral Hearing Loss, Health Services Research
Active, not recruiting
Clinical Utility of Residual Hearing in the Cochlear Implant Ear
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Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
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Not yet recruiting
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Active, not recruiting
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hearing Loss, Bilateral and Hearing Loss, Sensorineural, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hearing Handicap Inventory for the Elderly (time frame: Change from Baseline following 7-weeks of intervention use.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03674086, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.