Hearing aids and hearing speech in noise with age-related hearing loss
Tests a hearing aid in people with age-related hearing loss.
Key facts
- Who runs it
- University of South Florida
- Where
- Tampa, United StatesSee the site
- Trial code
- Registry title
- Understanding Aided Speech Perception in Noise
- Status
- Recruiting
- People taking part
- 121 people, planned
- Started
- 16 Nov 2025
- Expected to end
- 1 Mar 2028
- Type of study
- Interventional, 3 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Open-source master hearing aid
- Record updated
- 22 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young adults with normal hearing, older adults with normal hearing, and older adults with hearing loss in both ears. It studies how people hear speech in noise, with and without a hearing aid.
- Age
- 18 to 35 years for the younger group; 60 to 80 years for the older groups.
- Sex
- All sexes can join. The trial aims for a balance of men and women.
- Disease stage
- Normal-hearing groups: ≤20 dB HL at 0.25 to 4 kHz and ≤30 dB HL up to 8 kHz. Hearing-loss group: hearing loss of the inner ear or nerve (sensorineural) in both ears, similar on both sides, in the mild-to-moderately severe range. Thresholds 35 to 50 dB HL from 0.25 to 2 kHz and 50 to 70 dB HL between 3 and 8 kHz.
- Earlier treatment
- Hearing-loss group: people who could use hearing aids or who already use them.
- Biomarker or test result
- Hearing-loss group: a normal middle-ear test (Type "A" tympanogram) and a memory and thinking test (MoCA) score of > 22. Must speak English fluently.
Main reasons for not taking part
- Care in the past 12 months for head injury, traumatic brain injury, epilepsy, seizures or other nerve or brain disorders
- Ear surgery in the past 12 months
- Hearing loss that changes up and down, acute Meniere's disease or labyrinthitis
- Conductive hearing loss (from the outer or middle ear)
- Use of medicines that can damage hearing
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Target candidates for this study will be 38 young normal-hearing (YNH), 38 older normal-hearing (ONH), and 55 older hearing-impaired (OHI) subjects. Eligible NH listeners will have ≤20 dB HL at octave frequencies from 0.25 to 4 kHz and ≤30 dB HL up to 8 kHz. Eligible HI listeners will have bilateral (symmetric), moderate sensorineural hearing loss characterized by pure-tone thresholds between 35 to 50 dB HL from 0.25 to 2 kHz and 50 to 70 dB HL between 3 and 8 kHz. Age is restricted from 60 to 80 years for the older listening groups and from 18 to 35 for younger listeners. A balance of male and female participants will be recruited to assess sex as a biological variable in the data analyses. This age range for older listeners was chosen to be maximally inclusive of potential presbycusic participants, to promote generality of the results, and to facilitate uniform sampling within this age range. The investigators want to avoid the scientific need to stratify by age, which would make the scope of the project unmanageable given the constraints of this five-year award. The investigators have no evidence that lower or higher ages would affect aided intervention. Thus, inclusion of a larger age range would weaken the rigor of the investigation and complicate interpretation of the findings. The target range of hearing loss was chosen for similar reasons, reflecting the largest segment of older adults with hearing loss while avoiding the need to stratify by hearing loss to evaluate the stated hypotheses
- Additional Inclusion Criteria for HI group:
- Bilateral sensorineural hearing losses within the mild-to-moderately severe range as indicated by pure tone air- and bone-conduction audiometry and screening (Y-226 Hz, Type "A") tympanograms
- Candidates for hearing aids or experienced users
- Fluent speaker of English as speech testing will be in English
- MoCA (Montreal Cognitive Assessment; Nasreddine et al., 2005) score of > 22. This cut point has been used frequently in investigations of aging and will better ensure that cognitive related problems will not restrict the abilities of subjects to perform the study tasks
Who cannot take part
- Otologic surgical procedures
- Use of ototoxic medications
- Epilepsy
- Seizures
- Other neurological disorders
- Acute Meniere's disease
- Head trauma
- Traumatic brain injury
- Actively fluctuating hearing loss
- Labyrinthitis
- Conductive hearing loss
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Where in United States
- USF Research Park BPB, 3802 Spectrum Boulevard, Suite 210CTampa, United StatesContact: Erol Ozmeral, Ph.D.Taking people
About the trial
What the trial wants to find out
The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention.
The 3 groups in the trial
- Older listeners with hearing lossTreatment being tested
Test group, tested with and without the intervention (openMHA device) fit to their audiometric profile.
Treatment: Open-source master hearing aid
- Older listeners with normal hearingNo study treatment, for comparison
Control group, no intervention.
- Younger listeners with normal hearingNo study treatment, for comparison
Control group, no intervention.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Understanding Aided Speech Perception in Noise: Behavioral and Electrophysiological Measures
- Plain-language title
- Hearing aids and hearing speech in noise with age-related hearing lossGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Fit questions
- Built from NCT06377215, who can take part
- Record updated
- 22 December 2025