SpeechNCT05954520
Effects of Nonlinear Signal Processing Algorithms on Speech Perception
A study testing Tympan in people with Speech and Hearing Loss, Sensorineural, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Speech, Hearing Loss, Sensorineural, Hearing Aids
- What is being tested?
- Tympan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 9 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and 65
- Native speaker of English
- Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below.
Who cannot join
- Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss.
- Subjects who younger than 18 or older than 65.
- Subjects who are not native speakers of English.
- Subjects with thresholds more than 70 dB HL at 2000 Hz and below
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Sciences Building
Bloomington, Indiana, 47408
About this study
The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception.
Read the detailed description
In this study, we are interested in how nonlinear algorithms influence speech perception.
Nonlinear algorithms are used within hearing aids and personal sound amplifiers to provide comfort to the listener. One of these algorithms provides amplification (gain) in a manner that depends on the level of the input sound.: Low-level sounds are amplified much more than high-level sounds. This type of amplification makes sounds more comfortable for listeners, but also distorts incoming sounds. To determine the effect of these algorithms on speech understanding, we will evaluate the following factors on speech perception, within the context of these algorithms:
- The input Signal-to-Noise ratio (SNR) to the algorithm (3 different SNRs)
- The type of background noise (20 people talking or 2 people talking)
- Algorithm settings (slow and fast - whether changes to gain applied to fluctuating input sounds occurs quickly or slowly)
To address our questions, we are using a wearable processor (Tympan) that allows for real-time processing of audio signals. The Tympan itself contains microphones, a processor, and small earpieces that include speakers. A listener can wear the earpieces, like headphones, and listen to sounds processed by the Tympan in real time. The Tympan allows us access to the algorithms and to the sounds processed by the algorithms so that we cannot algorithm behavior to speech perception.
Our study will complement existing work on speech perception and nonlinear algorithms, but our study will be the first to use a wearable processor in which the specific algorithm is known, tailored to an individual's hearing levels, and which allows for direct calculation of the output SNR. Most studies also have not measured speech perception, and this will be one of only a handful of studies with that objective.
- Conditions
- Speech, Hearing Loss, Sensorineural, Hearing Aids
- Being tested
- Tympan
- Keywords
- speech perception, hearing aids
- Medical subject headings
- Speech, Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TympanDevice
Participants will wear a prototype hearing aid (called the Tympan)
| Study group | Role | What they receive |
|---|---|---|
| Perceptual measures | Experimental | Perception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio) Receives: Device: Tympan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech understanding
Percent words correct will be measured
Measured: 1-2 hours
Secondary outcomes (1)
Preference
Algorithm preference will be measured for each experimental condition
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2023
- Primary completion9 Jun 2025
- Study completion9 Jun 2025
Why it stopped: The student conducting this work took a job at another institution and is no longer continuing this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpeechStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer J Lentz, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954520
- Sponsor's protocol ID
- 18675
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2023
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nonlinear Signal Processing Algorithms on Speech Perception
- ClinicalTrials.gov ID
- NCT05954520
- Acronym / sponsor ID
- 18675
- Conditions
- Speech, Hearing Loss, Sensorineural, Hearing Aids
- Keywords
- speech perception, hearing aids
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The student conducting this work took a job at another institution and is no longer continuing this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 9 Jun 2025 (actual)
- Study completion
- 9 Jun 2025 (actual)
- First posted
- 20 Jul 2023 (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.
The purpose of this study is to investigate the effect of nonlinear signal processing algorithms on speech perception.
Detailed description
In this study, we are interested in how nonlinear algorithms influence speech perception.
Nonlinear algorithms are used within hearing aids and personal sound amplifiers to provide comfort to the listener. One of these algorithms provides amplification (gain) in a manner that depends on the level of the input sound.: Low-level sounds are amplified much more than high-level sounds. This type of amplification makes sounds more comfortable for listeners, but also distorts incoming sounds. To determine the effect of these algorithms on speech understanding, we will evaluate the following factors on speech perception, within the context of these algorithms:
- The input Signal-to-Noise ratio (SNR) to the algorithm (3 different SNRs)
- The type of background noise (20 people talking or 2 people talking)
- Algorithm settings (slow and fast - whether changes to gain applied to fluctuating input sounds occurs quickly or slowly)
To address our questions, we are using a wearable processor (Tympan) that allows for real-time processing of audio signals. The Tympan itself contains microphones, a processor, and small earpieces that include speakers. A listener can wear the earpieces, like headphones, and listen to sounds processed by the Tympan in real time. The Tympan allows us access to the algorithms and to the sounds processed by the algorithms so that we cannot algorithm behavior to speech perception.
Our study will complement existing work on speech perception and nonlinear algorithms, but our study will be the first to use a wearable processor in which the specific algorithm is known, tailored to an individual's hearing levels, and which allows for direct calculation of the output SNR. Most studies also have not measured speech perception, and this will be one of only a handful of studies with that objective.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perceptual measures | Experimental | Device: TympanPerception will be measured for different algorithm settings and environmental variables (type of noise and signal-to-noise ratio) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 18 and 65
- Native speaker of English
- Have bilateral, symmetric sensorineural hearing loss that is less than 75 decibels (dB) Hearing Level (HL) at 1000 Hz and below.
Key exclusion criteria (4 listed)
- Subjects with normal hearing, mixed hearing loss, or asymmetric sensorineural hearing loss.
- Subjects who younger than 18 or older than 65.
- Subjects who are not native speakers of English.
- Subjects with thresholds more than 70 dB HL at 2000 Hz and below
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 |
|---|---|---|
| TympanParticipants will wear a prototype hearing aid (called the Tympan) | Device | Perceptual measures |
Primary outcome
Speech understanding
Time frame: 1-2 hours
Percent words correct will be measured
1 secondary outcome
Preference
Time frame: 15 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tympan in people with Speech and Hearing Loss, Sensorineural, run by Indiana University at 1 site in United States.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech understanding (time frame: 1-2 hours). 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 12 Jun 2025.