NCT03674086

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

February 19, 2020

Status Verified

March 1, 2019

Enrollment Period

4 months

First QC Date

September 13, 2018

Last Update Submit

February 18, 2020

Conditions

Hearing Loss, BilateralHearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change from Baseline following 7-weeks of intervention use.

Secondary Outcomes (12)

  • Glasgow Hearing Aid Benefit Profile

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

  • Vanderbilt Fatigue Scale for Adults with Hearing Loss

    Change from Baseline following 7-weeks of intervention use.

  • Device-Orientated Subjective Outcome scale

    Change from Baseline following 7-weeks of intervention use.

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

    Change from Baseline following 7-weeks of intervention use.

  • Auditory Lifestyle and Demands Questionnaire

    Following 1-week of intervention use.

  • +7 more secondary outcomes

Study Arms (2)

First-time hearing aid user

Using hearing aids less than or equal to three months.

Device: eAdjust 0.2 hearing aid smartphone application (or app)

Existing hearing aid user

Using hearing aids for 6 months or more.

Device: eAdjust 0.2 hearing aid smartphone application (or app)

Interventions

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.

Existing hearing aid userFirst-time hearing aid user

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Health Research Nottingham Biomedical Research Centre

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

Location

Related Publications (1)

  • 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.

    PMID: 34653030DERIVED

MeSH Terms

Conditions

Hearing Loss, BilateralHearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2018

First Posted

September 17, 2018

Study Start

August 23, 2018

Primary Completion

December 14, 2018

Study Completion

April 30, 2019

Last Updated

February 19, 2020

Record last verified: 2019-03

Locations

GB(1)