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

NCT ID: NCT04843124

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hearing Aids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Remote hearing aid adjustment. All participants in this group are offered hearing aids possible to adjust remotely.

Group Type EXPERIMENTAL

Remote HA adjustment

Intervention Type DEVICE

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.

Control group

Traditional hearing aid adjustment

Group Type ACTIVE_COMPARATOR

Traditional hearing aid

Intervention Type OTHER

Traditional hearing aid

Interventions

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Remote 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.

Intervention Type DEVICE

Traditional hearing aid

Traditional hearing aid

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \<18 yr of age
* experienced hearing aid users
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sodra Alvsborgs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Milijana Malmberg

PhD, audiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hearing Clinic, Hearing Organization

Borås, Vastra Gotalandsregion, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Remote HA-fitting new

Identifier Type: -

Identifier Source: org_study_id