CClinicalTrials.gg
CompletedNCT06051968Updated Aug 12, 2026

Effects of an Online Hearing Support for First-time Hearing Aid Users

An interventional study of Online hearing support for first-time hearing aid users and Hearing rehabilitation according to common practice. in Hearing Loss, Hearing Impairment and Hearing Disorders, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

The goal of this randomised controlled trial is to test a online hearing support for first-time hearing aid users. The main questions it aims to answer are short- and long-term effects on the emotional and social consequences of hearing loss that the participants experience, use of communications strategies, experienced listening in complex sound environments and perceived effectiveness and satisfaction with hearing aids.

02

Conditions studied

  • Hearing Loss
  • Hearing Impairment
  • Hearing Disorders
  • Hearing Disability
  • Ear Diseases
  • Sensation Disorders
  • Otorhinolaryngologic Diseases
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults > 20 years of age that are eligible for hearing aids
  • Access to a computer, tablet and/or smartphone with internet
  • Access to a Swedish BankID or equivalent

Exclusion criteria

Exclusion Criteria:

  • Inability to read and understand Swedish
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Intervention group

    Participants get hearing rehabilitation according to common practice and the online hearing support.

    Behavioral: Online hearing support for first-time hearing aid users

  • Active comparator
    Control group

    Participants get hearing rehabilitation according to common practice.

    Behavioral: Hearing rehabilitation according to common practice.

Interventions

  • BehavioralOnline hearing support for first-time hearing aid users

    Participants get hearing rehabilitation according to common practice and the online hearing support consists of five chapters that aim to give information, support, and advice to the new hearing aid users. The participants are assigned a new chapter between each visit at the clinic.

    Also known as: Stöd och Behandling för nya hörapparatanvändare, Internetbaserat stöd vid hörselrehabilitering

  • BehavioralHearing rehabilitation according to common practice.

    Participants get hearing rehabilitation according to common practice.

05

What researchers measure

Primary outcomes

  1. The Hearing Handicap Inventory for the Elderly (HHIE)

    Assessing changes in emotional and social effects of hearing loss, self-perceived activity limitations and participation restrictions. Minimum 0 points to maximum 100 points. Higher score indicates greater emotional and social effects of hearing loss.

    Time frame: Baseline, directly post intervention and 6 months post intervention.

Secondary outcomes

  1. The 12-item Speech, Spatial and Qualities of Hearing Scale (SSQ12)

    Assessing experience of listening in complex sound environments. Minimum 0 points to 120 points. Higher score indicates less problems with hearing in the specified situations.

    Time frame: Baseline, directly post intervention and 6 months post intervention.

  2. Communication Strategies Scale (CSS)

    Assessing changes in use of verbal, non-verbal and maladaptive communication strategies. Minimum 25 points to maximum 125 points. Higher score indicates a greater use of communication strategies.

    Time frame: Baseline, directly post intervention and 6 months post intervention.

  3. The International Outcome Inventory for Hearing Aids (IOI-HA)

    Assessing changes in perceived effectiveness and satisfaction with hearing aids. Minimum 7 points to maximum 35 points. Higher score indicates higher perceived effect.

    Time frame: Directly post intervention and 6 months post intervention.

Other outcomes

  1. Subjective impact of the intervention, reported by the users: Memory of the intervention

    The participants are asked what they remember from their intervention.

    Time frame: 6 months post intervention

  2. Subjective impact of the intervention, reported by the users: Seeking more or other information

    The participants are asked if they searched for more or other information about hearing or hearing aids.

    Time frame: 6 months post intervention

  3. Subjective impact of the intervention, reported by the users: Adverse effects

    The participants are asked if they experienced any adverse effects of the intervention.

    Time frame: 6 months post intervention

06

Study locations

1 site
  • Audiologimottagningen Lund
    Lund, Sweden
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06051968
Lead sponsor
Region Skane
Collaborators
Horselvarden Region Ostergotland
Responsible party
Sponsor
First posted
Sep 25, 2023
Start date
Sep 18, 2023
Primary completion
Apr 7, 2026
Completion
Apr 7, 2026
Last update
Aug 12, 2026

Study contacts

Marie Öberg
principal investigator · Horselvarden Region Ostergotland

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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