NCT07756970

Brief Summary

Hearing speech in the presence of background noise is a significant challenge for those with hearing loss. Being able to hear speech in noise has been rated as the most sought-after feature in hearing aids by hearing aid users. Our study aims to evaluate the effects of adaptation to hearing test in noise on speech perception, spatial perception and satisfaction in bilateral hearing aid users. The development process of speech understanding in noise in individuals with hearing loss over the age of 50 will be monitored with ACT and ecological-HINT tests. Spatial perception will be assessed with the Speech, Spatial Perception and Hearing Quality (SHRQ) Scale, which is a scale that evaluates the current hearing quality in adults. The hearing aid satisfaction process of the participants will be assessed with the APHAB survey.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 31, 2025

Last Update Submit

August 8, 2026

Conditions

Keywords

audible contrast thresholdhearing aidhearing in noiseeko-HINTspatial perception

Outcome Measures

Primary Outcomes (1)

  • Eco-HINT

    Speech-in-noise performance was assessed using the ecologically valid Hearing in Noise Test (eco-HINT). Speech reception thresholds were measured under aided and unaided listening conditions. Lower scores indicate better speech-in-noise performance.

    1 week and 1 month after hearing aid fitting

Secondary Outcomes (2)

  • Speech, Spatial Perception and Hearing Quality Scale

    1 week and 1 month after hearing aid fitting

  • APHAB survey

    1 week and 1 month after hearing aid fitting

Other Outcomes (1)

  • Audible Contrast Threshold (ACT)

    Time Frame: 1 week and 1 month after hearing aid fitting

Study Arms (2)

Experimental Group

ACTIVE COMPARATOR

The ACT method will be applied to the study group in fitting, and the results will be recorded by applying the KUİK scale and APHAB survey after fitting. They will be called for control in the 1st week and 1st month, and fitting and scale evaluations will be made and the results will be recorded. Participants' discrimination in noise with ACT and Turkish Matrix Test, evaluation of spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be evaluated in the initial and 1st month time periods.

Diagnostic Test: ACT method in fitting

Control Group

ACTIVE COMPARATOR

The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting. Fitting and scale assessments will be made at week 1 and month 1, and the results will be recorded. Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception assessment with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1.

Diagnostic Test: Traditional fitting

Interventions

ACT method in fittingDIAGNOSTIC_TEST

The ACT diagnostic test is a suprathreshold, non-language-specific test that measures an individual's hearing ability in real-world noisy environments to determine the level of assistance needed in noise. The test uses the audiogram shape and levels to ensure the correct stimulus intensity is applied. The ACT test then uses the patient's audiogram to present a suprathreshold stimulus (a siren-like sound) to objectively map their hearing ability in noisy environments. In other words, the audiogram measures quantity, i.e. hearing ability, while the ACT measures the quality of hearing. This makes the ACT a robust assessment that reflects an individual's real-world hearing abilities.

Also known as: hearing in noise
Experimental Group
Traditional fittingDIAGNOSTIC_TEST

The control group will be fitted with traditional fittings, and the results will be recorded using the KUİK scale and APHAB survey after fitting. They will be called for a check-up at week 1 and month 1, and fitting and scale assessments will be made, and the results will be recorded. Participants' ability to discriminate in noise with the ACT and Turkish Matrix Test, spatial perception with the KUİK scale, and hearing aid satisfaction with the APHAB survey will be assessed at the beginning and month 1. All findings will be compared and statistically analyzed.

Control Group

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965)
  • SDS score between 70-100%
  • Being a bilateral hearing aid user
  • Being a user of Oticon, Philips, Bernafon hearing aids
  • Being between 18-50 years of age
  • Signing an informed consent form

You may not qualify if:

  • Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs
  • Complaining with tinnitus
  • Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test
  • Not signing an informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydın University

Istanbul, Kucukcekmece, 34295, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Orientation, Spatial

Interventions

HearingNoise

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Vestibulocochlear Physiological PhenomenaPhysiological PhenomenaSensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSoundRadiation, NonionizingRadiationPhysical PhenomenaEnvironmentEcological and Environmental PhenomenaBiological PhenomenaEnvironment and Public HealthEnvironmental PollutionPublic Health

Study Officials

  • Sule Cekic, associate professor

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR
  • Umıt Can Cetinkaya, assistant professor

    Istanbul Aydın University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Inclusion Criteria: Medium (41-55 dB) / moderate to severe (56-70 dB), sensorineural hearing loss (Goodman, 1965) SDS score between 70-100% Being a bilateral hearing aid user Being a user of Oticon, Philips, Bernafon hearing aids Being between 18-50 years of age Signing an informed consent form Exclusion Criteria: Conditions with variable hearing loss such as Meniere's disease, ongoing treatment with ototoxic drugs Complaining with tinnitus Low cognitive capacity: Scoring below 24 on the Standardized Mini Mental Test Not signing an informed consent form The ACT method will be applied to the study group in fitting, the KUİK scale and APHAB survey will be applied after fitting and the results will be recorded. The control group will be applied with traditional fitting, the KUİK scale and APHAB survey will be applied after fitting and the results will be recorded.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

March 31, 2025

First Posted

August 11, 2026

Study Start

February 13, 2025

Primary Completion

May 2, 2025

Study Completion

June 1, 2025

Last Updated

August 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

To ensure the privacy and confidentiality of participants, individual participant data (IPD) will not be shared. Since the study involves hearing aid users, it is extremely important to protect the integrity of their personal data. Furthermore, the guidelines of the ethics committee and institutional policies require strict data protection to prevent possible misuse. Therefore, IPD will remain confidential and will not be made public.

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