Speech Manipulation for Hearing Loss

Recruiting at 2 trial locations

Overseen By Christian Stilp, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Louisville

Disqualifiers: Cognitive disabilities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 year

680 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how individuals with hearing loss recognize speech sounds and how context influences their understanding. Researchers aim to determine how background noise complicates speech recognition for those with hearing difficulties, particularly users of hearing aids or cochlear implants. Participants will listen to speech sounds and report what they hear, aiding in the enhancement of future hearing aid and implant technologies through speech manipulation techniques. Suitable candidates for this trial are adults who can recognize spoken English and either have normal hearing or use a cochlear implant. As an unphased trial, this study allows participants to contribute to advancements in hearing technology and improve future solutions for those with hearing loss.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this speech manipulation is safe for participants?

Research shows no specific safety information is available for the treatment called Speech Manipulation for Hearing Loss. This treatment involves listening to and recognizing speech sounds, generally considered safe because it doesn't use drugs or involve surgery. However, without direct safety studies, solid proof of tolerance cannot be provided. The trial is in a phase called "Not Applicable," focusing more on observing and testing rather than using new medical devices or drugs. Therefore, the risk of side effects is likely low, but discussing any concerns with the study team before deciding to join is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the speech manipulation technique for hearing loss because it offers a fresh approach compared to traditional hearing aids and cochlear implants. Unlike these devices, which amplify sound or bypass damaged parts of the ear, speech manipulation focuses on enhancing the brain's ability to process speech more clearly. This technique could lead to improved speech perception without the reliance on external devices, potentially making communication easier and more natural for individuals with hearing loss.

What evidence suggests that speech manipulation is effective for hearing loss?

Research has shown that certain techniques can help people with hearing loss understand speech better. One study found that half of the participants with cochlear implants improved their ability to hear speech in noisy environments after special training. This suggests that the right methods can help those with hearing aids or cochlear implants recognize speech more clearly. Additionally, training that combines listening and thinking skills has proven effective in helping people, especially those with severe hearing issues, hear speech better in noisy settings. These findings demonstrate that using surrounding sounds and context can enhance speech understanding for those with hearing difficulties. Participants in this trial will engage in speech perception experiments to explore these techniques further. ^{1 2 6 7 8}

Who Is on the Research Team?

Christian Stilp, PhD

Principal Investigator

Marquette University

Are You a Good Fit for This Trial?

This trial is for individuals with varying degrees of hearing loss, including those who use hearing aids or cochlear implants. It aims to understand how they perceive speech in different acoustic contexts and the impact of background noise on their recognition abilities.

Inclusion Criteria

Be able to recognize spoken words in English

Have normal audiometric thresholds below 25 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds not exceeding 40 dB HL at frequencies between 250 and 8000 Hz OR have audiometric thresholds not exceeding 55 dB HL at frequencies between 250 and 8000 Hz OR use a cochlear implant

I am fluent in North American English.

Exclusion Criteria

Not a competent speaker of North American English

I am under 18 years old.

I am older than 65.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Audiometric threshold testing to determine the lowest sound intensity detectable by participants

1 week

1 visit (in-person)

Treatment

Participants undergo systematic manipulation of speech sounds to evaluate speech categorization and recognition

1 year

Multiple sessions (in-person)

Follow-up

Participants are monitored for outcomes and data is reported through study completion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Speech Manipulation

Trial Overview

The study investigates how people with healthy and impaired hearing recognize speech sounds within context. It will explore the role of adjacent sounds and examine if modifications to hearing devices can improve perception.

How Is the Trial Designed?

Group I: Speech perception experiments Experimental Treatment 1 Intervention

This arm involves experiments wherein participants listen to speech played at comfortable volumes and respond by indicating what they heard either in open-ended form or by choosing among a set of options displayed on a computer.

Who Is Running the Clinical Trial?

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Enhancing specific acoustic features of consonants significantly improved speech perception in hearing-impaired individuals, with 75% of participants achieving at least 90% accuracy in identifying stop voicing sounds after the enhancements.

A single training session using these enhanced consonant sounds was effective in maximizing performance improvements, indicating that targeted acoustic modifications can be a practical intervention for improving speech perception in those with severe to profound hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Speech-cue enhancement for the hearing impaired: amplification of burst/murmur cues for improved perception of final stop voicing. Revoile, SG., Holden-Pitt, L., Edward, D., et al.[2007]

The Cochlear Nucleus Hybrid L24 implant significantly improves speech intelligibility for individuals with severe high-frequency hearing loss and some low-frequency hearing, with average gains of 35.8 percentage points in consonant-nucleus-consonant words and 32.0 percentage points in AzBio sentences in noise, both statistically significant (P < 0.001).

A high percentage of subjects (96%) performed equally or better in speech perception in quiet environments, and 90% did so in noisy settings, indicating that this device is effective for individuals who previously struggled with traditional amplification methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States multicenter clinical trial of the cochlear nucleus hybrid implant system. Roland, JT., Gantz, BJ., Waltzman, SB., et al.[2021]

A review of adverse event reports indicated that hearing loss associated with otic medications primarily affects older dogs, particularly those over 10 years old, with no specific products linked to increased risk.

Hearing loss may result from various factors beyond ototoxicity, including the underlying ear conditions, age-related hearing decline, or other anatomical issues, highlighting the need for thorough evaluation and reporting of such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hearing loss following the use of topical otitis therapeutics in dogs]. Neubert, A., Tannert, S., Pirk, G.[2022]

A study involving hearing aid users aged 16-89 in Nigeria found that aural rehabilitation significantly improves self-reported outcomes across various domains, including daily use and satisfaction, with mean scores comparable to those in developed countries.

The results indicate that aural rehabilitation is both feasible and effective in enhancing the quality of life for hearing-impaired individuals in a developing country, with most respondents reporting favorable outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported outcomes of aural rehabilitation in a developing country. Olusanya, B.[2019]

Providing a clear speech intervention to spouses of individuals with hearing loss resulted in significant improvements in speech clarity and recognition, allowing those with hearing loss to perform as well as individuals with normal hearing.

Simply instructing a talker to speak clearly was less effective than a structured intervention, as it did not produce the same level of speech parameter changes or stability, highlighting the importance of targeted training for better communication outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clear speech for adults with a hearing loss: does intervention with communication partners make a difference? Caissie, R., Campbell, MM., Frenette, WL., et al.[2020]

In a study of four profoundly deafened adults, simplified feedback on voice fundamental frequency (Fx) led to better control of voice pitch compared to traditional amplified speech feedback, particularly for those with impaired control.

The results suggest that using simplified Fx feedback could enhance speech-processing strategies in hearing aids and cochlear implants, as it showed improved or maintained Fx control in subjects who struggled with traditional feedback methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of two different speech-coding strategies on voice fundamental frequency control in deafened adults. Ball, V., Faulkner, A., Fourcin, A.[2019]

In a review of 1,835 articles from major otolaryngology journals, only 31% provided therapeutic recommendations, and 65% mentioned harms or adverse events, indicating a significant underreporting issue.

Studies that reported beneficial effects of therapy were more likely to omit details about adverse events, suggesting a potential bias in reporting, while surgical studies were more likely to document harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of harms and adverse events in otolaryngology journals. Bibawy, H., Cossu, A., Cogan, S., et al.[2009]

The speech-enhancement process developed for hearing-impaired listeners significantly improved speech intelligibility in noisy environments, particularly at speech-to-noise ratios between -3 and 6 dB.

This enhancement technique, which modifies the auditory excitation pattern of speech signals, showed small but meaningful improvements for subjects with moderate to severe sensorineural hearing loss, indicating its potential effectiveness in real-world listening situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectral Enhancement to Improve the Intelligibility of Speech in Noise for Hearing-impaired Listeners. Simpson, AM., Moore, BCJ., Glasberg, BR.[2020]

The speech-enhancement process developed for hearing-impaired listeners significantly improved speech intelligibility in noisy environments, particularly at speech-to-noise ratios between -3 and 6 dB.

This enhancement technique, which modifies the auditory excitation pattern of speech signals, showed small but meaningful improvements for subjects with moderate to severe sensorineural hearing loss, indicating its potential effectiveness in real-world listening situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectral enhancement to improve the intelligibility of speech in noise for hearing-impaired listeners. Simpson, AM., Moore, BC., Glasberg, BR.[2008]

Advancements in speech-recognition and processing technology could significantly help people with hearing impairments by automatically enhancing important speech sounds, making them easier to hear.

The study outlines methods for determining which speech sounds need enhancement and how much amplification is necessary, as well as the potential training required for hearing-impaired individuals to effectively use these enhancements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Some rehabilitative considerations for future speech-processing hearing aids. Revoile, SG., Holden-Pitt, LD., Edward, DM., et al.[2012]

The authors advocate for using the auditory brainstem response (ABR) as the sole method for ototoxicity testing in nonclinical safety assessments, arguing it is more efficient and less burdensome than including distortion product otoacoustic emissions (DPOAEs).

They emphasize that using both ABR and DPOAEs increases operational challenges and poses health risks to animals due to the need for extended anesthesia, while ABR alone provides sufficient and reliable data for assessing potential auditory harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distortion Product Otoacoustic Emission Test is Not the Test to Use in Nonclinical Safety Assessment. Gauvin, DV., McComb, M., Tapp, R., et al.[2022]

Safety pharmacology studies are essential in drug development to evaluate the potential effects of new drugs on auditory functions, ensuring that they do not cause hearing loss at therapeutic doses.

The chapter emphasizes the importance of identifying the specific mechanisms behind any observed hearing loss, as well as adhering to FDA standards when designing ototoxicity studies to assess drug interactions with the auditory system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety Pharmacology of Auditory Function. Abernathy, MM.[2015]

A study involving eight hearing-impaired adults showed that communication therapy can effectively change how individuals use repair strategies when they misinterpret spoken sentences, leading to a more diverse approach in communication.

After therapy, participants reduced their reliance on the 'repeat' strategy and began using other strategies, such as asking for simplification or key words, indicating improved communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repair strategy usage by hearing-impaired adults and changes following communication therapy. Tye-Murray, N.[2019]

Both younger and older talkers were able to significantly improve their speech intelligibility for hearing-impaired listeners after minimal instruction and practice, demonstrating that clear speech can be effectively taught.

The study suggests that teaching clear speaking techniques can be a beneficial intervention for family members of elderly patients with hearing loss, as both age groups showed similar improvements in intelligibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intelligibility of clear and conversational speech of young and elderly talkers. Schum, DJ.[2020]

A communication education program for older adults with hearing impairment, involving 96 participants over five weeks, showed positive outcomes and high satisfaction, as measured by the International Outcome Inventory--Alternative Interventions (IOI-AI).

The results from this program were comparable to other audiological interventions, suggesting that the IOI-AI and its version for significant others (IOI-AI-SO) are effective tools for assessing the impact of alternative communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring outcomes of a communication program for older people with hearing impairment using the International Outcome Inventory. Hickson, L., Worrall, L., Scarinci, N.[2019]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10503297/

Effectiveness of Auditory Training in Experienced Hearing-Aid ...

Results showed that half of the cochlear implant users showed better speech in noise perception and better quality of life following training.

2.

withpower.com

withpower.com/trial/speech-manipulation-for-hearing-loss-7fbb0

Speech Manipulation for Hearing Loss

Trial Overview The study investigates how people with healthy and impaired hearing recognize speech sounds within context. It will explore the role of adjacent ...

3.

pubs.asha.org

pubs.asha.org/doi/10.1044/2023_AJA-23-00078

Effectiveness of Computerized Auditory Training on ...

The purpose of this study was to investigate the effectiveness of using computerized auditory training in the auditory perception of speech in children.

4.

nature.com

nature.com/articles/s41539-025-00306-5

Immersive auditory-cognitive training improves speech-in- ...

Immersive ACT exposure resulted in increased speech-in-noise perception, particularly for individuals with more pronounced hearing loss or reduced auditory ...

5.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK616586/

Outcomes for Hearing Health Interventions - NCBI - NIH

The most common treatment for sensorineural hearing loss involves amplifying the incoming signal to improve hearing function. This is accomplished most often ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8960939/

Hearing and Speech Perception for People With ...

Regarding the sound-field audiometry, all devices showed significant improvement between aided and unaided thresholds in all groups. Significant ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/P970051S205B.pdf

Summary of Safety and Effectiveness Data (SSED)

For co-primary effectiveness endpoint 1, results suggest that age at implant, duration of hearing loss, preoperative speech in noise score and.

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S2949916X24000860

Artificial intelligence for hearing loss prevention, diagnosis, ...

This paper explores the transformative impact of artificial intelligence (AI), particularly machine learning (ML), on diagnosing and treating hearing loss.