Evaluation of the eAdjust Application

Hearing Loss, Sensorineural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674086
• Other study ID #: 18IH002
• Status: Completed
• Start date: August 23, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2019
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 30, 2019
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. First-time (using hearing aids < 3 months)

2. 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.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Bilateral
• Hearing Loss, Sensorineural

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United Kingdom	National Institute for Health Research Nottingham Biomedical Research Centre	Nottingham	Non-US/Non-Canadian

Sponsors (3)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	Sonova AG, University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline (Part I) and following 7-weeks of intervention use (Part II).
Secondary	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.	Change from Baseline following 7-weeks of intervention use.
Secondary	Device-Orientated Subjective Outcome scale	Self-report questionnaire suitable for quantifying subjective hearing aid outcomes. Scored using a seven-point response scale.	Change from Baseline following 7-weeks of intervention use.
Secondary	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.	Change from Baseline following 7-weeks of intervention use.
Secondary	Auditory Lifestyle and Demands Questionnaire	Self-report measure of auditory lifestyle.	Following 1-week of intervention use.
Secondary	Clarity and Comfort Questionnaire	Self-report measure of hearing aid preferences concerning sound clarity and comfort.	Following 1-week of intervention use.
Secondary	Hearing aid datalogging	Hearing aid use in hours, internal to the hearing aid.	Following 1-week and 7-weeks of intervention use.
Secondary	Montreal Cognitive Assessment	Validated screening tool for mild cognitive impairment.	Following 1-week of intervention use.
Secondary	BKB Speeh-In-Noise Test	Behavioural measure of speech intelligibility in the presence of background noise.	Following 1-week and 7-weeks of intervention use.
Secondary	eAdjust 0.2 app datalogging	Usage data, internal to the app.	Following 2-week and 6-weeks of intervention use.
Secondary	App real-world use questionnaire	Self-report questionnaire of app usage. Consists of closed- and open-ended questions.	Following 2-week and 6-weeks of intervention use.
Secondary	Hearing aid tasks	Self-report questionnaire of app functionality in different environments.	Following 2-week and 6-weeks of intervention use.