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Not yet recruitingNCT07866586Updated Oct 8, 2026

New Hearing Aid Users and Their Social Participation

An observational study in Hearing Loss, Hearing Aids and Social Participation, sponsored by University of Nottingham. Not yet recruiting. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by University of Nottingham · Observational

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
50 Years to 90 Years
Sex
All
01

Study summary

Does first-ever hearing aid fitting change social participation?

Using a mixed methods approach made up of audiological assessments (hearing test and examination of the ear canal and eardrum), questionnaires, semi-structured interview and surveys, the study aims to gain a comprehensive and in-depth understanding of the experiences (in the first 12-13 months) of initial hearing aid users in relation to their social participation.

PRIMARY OBJECTIVE The primary outcome measures will be to compare scores on the ecological momentary assessment (EMA) ratings of social engagement and experience for social participation situations over the course of a participant's 13-month involvement in the study.

Differences in an individual's social networks analysis (SNA) will be examined in this longitudinal study to see if there are changes in social structure over time. This will involve looking at the network size, number of connections related to activities someone does, how they feel about the social connections and the support they get from their social network.

Assessing longitudinal changes in:

  • International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire - effectiveness of hearing aid(s).
  • Revised Hearing Handicap Inventory (RHHI) - emotional and social impacts of hearing loss.
  • Social Participation Restrictions Questionnaire (SPaRQ) - how hearing limits social life
  • The Hearing-Related Lifestyle Questionnaire (HEARLI-Q) - the influence of hearing ability in everyday listening situations.

Qualitative outcome measures - investigating the semi-structured interview and open text box response answers over the longitudinal study to explore personal perspectives, motivations and responses to questions related to social participation difficulties and avoidance, using reflexive thematic analysis

02

Conditions studied

  • Hearing Loss
  • Hearing Aids
  • Social Participation

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03

In context

Hearing Loss

1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.

This study's planned enrollment of 32 is below the median of 87 across 270 observational studies indexed under Hearing Loss.

Browse Hearing Loss studies →

Lead sponsor

University of Nottingham is the lead sponsor of 456 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants will be recruited from NHS Greater Glasgow and Clyde audiology departments and be people awaiting first fit of hearing aid(s)

Inclusion criteria

  • Adults aged 50 - 90 years (inclusive).
  • Ability to give informed consent.
  • Presence of a hearing loss (with a 4-frequency average (0.5-4kHz) of hearing thresholds greater than 25 dB HL in their better hearing ear).
  • Awaiting first ever fitting of hearing aid(s).
  • Available for the study visits over 13 months (e.g. not expected to be moving out of the local area).
  • Sufficient command of English to read, understand and complete questionnaires

Exclusion criteria

Exclusion Criteria:

  • Ear pathologies - acute or chronic middle ear diseases.
  • Troublesome tinnitus.
  • Fluctuating hearing loss.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (estimated)
Target follow-up
13 Months
Patient registry
Yes

Interventions

  • OtherObservation

    Longitudinal designed study over 13-months in first-ever adult hearing aid users, using a mixed methods approach with audiological assessments (hearing test and examination of the ear canal and eardrum), questionnaires, semi-structured interviews and smart-phone surveys.

06

What researchers measure

Primary outcomes

  1. Scores on EMA ratings

    The primary outcome measures will be to compare scores on the ecological momentary assessment (EMA) ratings of social engagement and experience for social participation situations over the course of a participant's 13-month involvement in the study. Ratings of engagement and experience are on a 5-point likert scale with '5' indicating the most positive engagement/experience.

    Time frame: from enrolment to 12 months post first hearing aid fitting

Secondary outcomes

  1. Assessing longitudinal changes in questionnaire scores - International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire

    Looking at the effectiveness of hearing aid(s). A seven item questionnaire (with five ordinal response options for each item). Scoring ranges from a min-max of 7-35 respectively, with a higher total score indicating a better overall outcome and greater hearing aid satisfaction

    Time frame: From study enrolment to 12 months post hearing aid fitting

  2. Assessing longitudinal changes in questionnaire scores - Revised Hearing Handicap Inventory (RHHI)

    Examining the emotional and social impacts of hearing loss. 18 item questionnaire and responses are scored (yes = 4, sometimes = 2, and no = 0). Range of scoring is 0 -72 with higher scores showing a greater psychosocial impact ( or a worse outcome)

    Time frame: From study enrolment to 12 months post hearing aid fitting

  3. Assessing longitudinal changes in questionnaire scores - Social Participation Restrictions Questionnaire (SPaRQ)

    A questionnaire looking at how hearing limits social life, with two subscales (nine items for social behaviours and ten items for social perceptions). Each item is rated on a scale from 0 (completely disagree) to 10 (completely agree). Higher scores indicate worse outcomes (greater restrictions in social participation caused by hearing loss) .

    Time frame: From study enrolment to 12 months post hearing aid fitting

  4. Assessing longitudinal changes in questionnaire scores - The Hearing-Related Lifestyle Questionnaire (HEARLI-Q)

    This questionnaire examines the influence of hearing ability in everyday listening situations. Asking about: * frequency of occurrence (ranges from never (0) to daily (4)), * importance to hear well (not important (0) to extremely important (4)), * hearing difficulty (not difficult (0) to extremely difficult (4)) * hearing aid satisfaction (not satisfied (1) to extremely satisfied (5)) Scored according to richness of lifestyle (relates to frequency of occurrence with higher score implying greater frequency), hearing demand (the occurrence and importance score combined ) - with higher scores suggesting more demand on hearing. Hearing difficulty and hearing aid satisfaction look at the mean across the listening situations. The higher score on hearing difficult suggests more challenge while a high score on hearing aid satisfaction suggests more positive/beneficial use of hearing aids

    Time frame: From study enrolment to 12 months post hearing aid fitting

  5. Qualitative analysis of semi-structured interview and open text box responses

    Qualitative outcome measures - investigating the semi-structured interview and open text box response answers over the longitudinal study to explore personal perspectives, motivations and responses to questions related to social participation difficulties and avoidance, using reflexive thematic analysis.

    Time frame: from enrolment to 12 months post hearing aid fitting

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Study protocol · Jul 15, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Anonymised participant data may be shared for research related purposes to: * allow peer scrutiny * re-use (and therefore avoiding duplication of research) * understand the bigger picture in particular areas of research.

Supporting information: Study protocol, Analytic code

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07866586
Lead sponsor
University of Nottingham
Collaborators
NHS Greater Glasgow and Clyde, WSAUD A/S
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Oct 8, 2026

Study contacts

Lindsey L Steele, MSc Audiology
Contact
lindsey.steele@nottingham.ac.uk
+44 (0) 141 2429665

Oversight

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

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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