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Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial (RCT)

Remote Hearing Aid Adjustment for New Hearing Aid Users; a Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04843124
Acronym
RCT
Enrollment
69
Registered
2021-04-13
Start date
2021-02-01
Completion date
2023-08-30
Last updated
2023-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Aids

Brief summary

Many hearing aid users experience substantial communication difficulties that may affect their participation in daily life situations negatively. One of the reasons for experiencing remaining problems could be due to unrealistic expectations, another reason could be that the hearing aid is not well adjusted or that the hearing aid user didn't got sufficient support and follow-up from the audiologist. The purpose of this project is to offer remote hearing aid adjustment as an additional support for new hearing aid users.

Interventions

DEVICERemote HA adjustment

The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.

OTHERTraditional hearing aid

Traditional hearing aid

Sponsors

Sodra Alvsborgs Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* \>18 yr of age * new hearing aid user

Exclusion criteria

* \<18 yr of age * experienced hearing aid users

Design outcomes

Primary

MeasureTime frameDescription
Hearing Handicap Inventory for the Elderly/Adults (HHIE/A)Change is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.Assessing emotional and social outcomes of a hearing loss; minimum 0 points to maximum 100 points, a higher score means worse outcome.

Secondary

MeasureTime frameDescription
The Abbreviated Profile of Hearing Aid Benefit (APHAB)Change is being assessed: at baseline, directly after completed rehabilitation, 6 months post and 1 year post.Measures subjective hearing loss in four typical hearing situations (subscales). There are six items for each subscale. Each item is answered for without my hearing aid and with my hearing aid. Each item is a statement associated with a percentage of occasions (1%\_Never, 12%\_Seldom, 25%\_Occasionally, 50%\_Half-the-time, 75%\_Generally, 87%\_Almost Always, 99%\_Always)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026