Hearing LossNCT07866586
New Hearing Aid Users and Their Social Participation
An observational study of Hearing Loss and Hearing Aids, run by University of Nottingham.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Hearing Loss, Hearing Aids, Social Participation
- What is being tested?
- Observation
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Jun 2028
- How long will I take part?
- 13 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from NHS Greater Glasgow and Clyde audiology departments and be people awaiting first fit of hearing aid(s)
Who may be able to join
- 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
Who cannot join
- Ear pathologies - acute or chronic middle ear diseases.
- Troublesome tinnitus.
- Fluctuating hearing loss.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Investigating the Impact of Hearing Aids on Social Participation in First-time Adult Hearing Aid Users: A 13-month Longitudinal Study
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.
Read more
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
- Conditions
- Hearing Loss, Hearing Aids, Social Participation
- Being tested
- Observation
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrolment to 12 months post first hearing aid fitting
Secondary outcomes (8)
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
Measured: From study enrolment to 12 months post hearing aid fitting
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)
Measured: From study enrolment to 12 months post hearing aid fitting
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) .
Measured: From study enrolment to 12 months post hearing aid fitting
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) - Formula: sum of all occurrence scores/92 X 100
Measured: From study enrolment to 12 months post hearing aid fitting
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 hearing demand (the occurrence and importance score combined to create a percentage score) - with higher scores suggesting more demand on hearing.
(Formula: sum of (occurrence x importance)/ 368 X 100 )
Measured: From study enrolment to 12 months post hearing aid fitting
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 hearing difficulty - taking the mean of all rated difficulty scores. A higher score indicates greater difficulty.
Measured: From study enrolment to 12 months post hearing aid fitting
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 hearing aid satisfaction - looking at the mean across all rated listening situations. The higher score o on hearing aid satisfaction suggests more positive/beneficial use of hearing aids
Measured: From study enrolment to 12 months post hearing aid fitting
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.
Measured: from enrolment to 12 months post hearing aid fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
- Target duration
- 13 Months
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, WSAUD A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07866586
- Sponsor's protocol ID
- 26030
- Other IDs
- IRAS Project ID: 361928
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Hearing Aids on Social Participation in First-time Adult Hearing Aid Users: A 13-month Longitudinal Study
- ClinicalTrials.gov ID
- NCT07866586
- Acronym / sponsor ID
- 26030
- Conditions
- Hearing Loss, Hearing Aids, Social Participation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde, WSAUD A/S
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 13 Months
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from NHS Greater Glasgow and Clyde audiology departments and be people awaiting first fit of hearing aid(s)
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- Ear pathologies - acute or chronic middle ear diseases.
- Troublesome tinnitus.
- Fluctuating hearing loss.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationLongitudinal 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. | Other | – |
Primary outcome
Scores on EMA ratings
Time frame: from enrolment to 12 months post first hearing aid fitting
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.
8 secondary outcomes
Assessing longitudinal changes in questionnaire scores - International Outcome Inventory for Hearing Aids (IOI-HA) questionnaire
Time frame: From study enrolment to 12 months post hearing aid fitting
Assessing longitudinal changes in questionnaire scores - Revised Hearing Handicap Inventory (RHHI)
Time frame: From study enrolment to 12 months post hearing aid fitting
Assessing longitudinal changes in questionnaire scores - Social Participation Restrictions Questionnaire (SPaRQ)
Time frame: From study enrolment to 12 months post hearing aid fitting
Assessing longitudinal changes in questionnaire scores - The Hearing-Related Lifestyle Questionnaire (HEARLI-Q)
Time frame: From study enrolment to 12 months post hearing aid fitting
Assessing longitudinal changes in questionnaire scores - The Hearing-Related Lifestyle Questionnaire (HEARLI-Q)
Time frame: From study enrolment to 12 months post hearing aid fitting
Assessing longitudinal changes in questionnaire scores - The Hearing-Related Lifestyle Questionnaire (HEARLI-Q)
Time frame: From study enrolment to 12 months post hearing aid fitting
Assessing longitudinal changes in questionnaire scores - The Hearing-Related Lifestyle Questionnaire (HEARLI-Q)
Time frame: From study enrolment to 12 months post hearing aid fitting
Qualitative analysis of semi-structured interview and open text box responses
Time frame: from enrolment to 12 months post hearing aid fitting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss and Hearing Aids, run by University of Nottingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsey L Steele, MSc Audiology (+44 (0) 141 2429665, lindsey.steele@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on EMA ratings (time frame: from enrolment to 12 months post first hearing aid fitting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.