Hearing Aids for Central Auditory Processing Disorder

(SBA Trial)

Recruiting at 2 trial locations

Overseen By Akai R McKinley, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Auditory medications

Disqualifiers: Conductive hearing impairment, Chronic disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 5 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Veterans experiencing hearing issues after exposure to a blast, despite normal hearing test results. Researchers will test a new method of fitting hearing aids by adjusting settings using speech sounds, rather than the standard method based on typical hearing tests. Participants will use Phonak Lumina P90 hearing aids, and the trial will compare the two fitting methods to determine which better aids speech understanding in noisy environments. Veterans who have experienced the blast of a high-intensity explosion and report hearing difficulties may be suitable candidates for this study. As an unphased trial, it offers Veterans the chance to explore innovative solutions for hearing challenges.

Will I have to stop taking my current medications?

The trial excludes participants who use medication that might affect the auditory system or their ability to perform the experimental tasks, so you may need to stop certain medications. It's best to discuss your specific medications with the trial team to see if they are affected.

What prior data suggests that these hearing aids are safe for Veterans with functional hearing difficulties?

Research shows that Phonak Lumina P90 hearing aids are designed to improve speech clarity and understanding. They use Phonak SmartSpeech Technology to enhance conversations in various settings.

In previous studies, users reported high satisfaction with these hearing aids. A similar model, the Audéo Lumity, received positive feedback during a two-week trial, with users noting daily satisfaction. This suggests that the hearing aids are comfortable and free from major issues.

While specific information on side effects is unavailable, positive feedback from past users indicates the hearing aids' safety and comfort. Prospective trial participants may find this information reassuring regarding their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring different hearing aid fitting methods for Central Auditory Processing Disorder (CAPD) because they aim to tailor the hearing aid experience more precisely to individual needs. Unlike traditional hearing aids, which often use a standard audiogram-based fitting, the experimental approach utilizes speech-based audiometry to customize settings. This could potentially enhance how users process speech, particularly in noisy environments. By comparing these two fitting methods, researchers hope to discover which one offers better outcomes for people with CAPD, thereby advancing personalized hearing care.

What evidence suggests that this trial's hearing aid treatments could be effective for functional hearing difficulties?

Research has shown that Phonak Lumina P90 hearing aids can help people hear more clearly and understand speech better, which is crucial for those with central auditory processing disorders. In this trial, participants will join one of two treatment arms: the Speech-based hearing aid fitting or the Audiogram-based hearing aid fitting. These hearing aids are designed to improve speech understanding in noisy environments, a significant challenge for individuals with functional hearing difficulties (FHDs). Studies indicate that Phonak's SmartSpeech Technology greatly aids in following conversations in difficult listening situations. Past users have reported improved speech understanding and listening skills. This suggests that these hearing aids could be very beneficial for Veterans with FHDs after blast exposure. ^{1 2 6 7 8}

Who Is on the Research Team?

Jonathan Venezia, PhD

Principal Investigator

VA Loma Linda Healthcare System, Loma Linda, CA

Are You a Good Fit for This Trial?

This trial is for blast-exposed Veterans who have trouble hearing in noisy places but have normal hearing tests. They should not already be using a low-gain hearing aid and must be able to complete speech recognition tasks and undergo neuroimaging.

Inclusion Criteria

All subjects must score 20 or higher on the Hearing Handicap Inventory for Adults (HHIA)

A score of at least 25 on the Mini Mental State Exam

Human subjects will be male or female Veterans selected without regard to race or ethnic background

Exclusion Criteria

I have hearing loss not caused by nerve damage.

I cannot perform the tasks required in the study.

Experience with hearing aids prior to the study

Timeline for a Trial Participant

Prescreening, Screening, and Enrollment

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person), 1 call (virtual)

Preparatory Period

Participants undergo speech-based audiometry and real ear measurement to prepare for hearing aid intervention

2 weeks

2 visits (in-person)

Baseline

Baseline outcome measures are obtained, including fMRI scan and speech-in-noise evaluation

1 week

2 visits (in-person)

Treatment

Participants receive hearing aid intervention with weekly visits for gain verification and outcome assessments

5 weeks

5 visits (in-person)

Follow-up

Participants complete final outcome assessments, including fMRI scan and speech-in-noise evaluation

1 week

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Phonak Lumina P90

Trial Overview The study compares two ways of fitting low-gain hearing aids: the usual method based on pure-tone audiograms, and a new data-driven approach using patient responses to speech in noise. It measures how well participants recognize speech with background noise and their brain activity during these tasks.

How Is the Trial Designed?

Group I: Speech-based hearing aid fitting Experimental Treatment 1 Intervention

Half of the study participants receive a hearing aid with gain settings determined via speech-based audiometry. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.

Group II: Audiogram-based hearing aid fitting Active Control 1 Intervention

Half of the study participants receive a hearing aid with gain settings determined by applying the NAL-NL2 prescriptive formula to the pure-tone audiogram. Other hearing aid features such as noise reduction and directional microphones are disabled. Of this group of subjects, half are assigned to use the hearing aid daily for six weeks, while the remainder are followed for the same six-week period but use their hearing aids only to complete outcomes testing.

Phonak Lumina P90 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Phonak Audeo Lumity 90 for:

• Mild to profound sensorineural hearing loss
• Functional hearing difficulties (FHDs)

Approved in European Union as Phonak Lumina P90 for:

• Mild to profound sensorineural hearing loss

Approved in Canada as Phonak Audeo Lumity 90 for:

• Mild to profound sensorineural hearing loss

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

NADI Inc.

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

In a study of 224 older adults who received bone-anchored hearing aids (BAHAs), the implant loss rate was 6.5% over an average follow-up of 39 months, which is comparable to rates seen in the general population.

Severe skin reactions occurred in 16.9% of implants, but the overall outcomes were favorable, with low risks of complications and no infections leading to implant loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone-anchored hearing aid surgery in older adults: implant loss and skin reactions. de Wolf, MJ., Hol, MK., Mylanus, EA., et al.[2022]

The selective AMPA receptor antagonist NS1209 showed potential in preclinical studies for treating neuropathic pain and epilepsy, but the clinical trials were poorly designed and yielded inconclusive results, leading to its removal from the CNS development pipeline.

Despite initial promise, NS1209's development was hindered by slow progress and insufficient data, highlighting the challenges in CNS drug discovery and the need for better trial designs to improve the chances of success for similar compounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NS1209/SPD 502, A Novel Selective AMPA Antagonist for Stroke, Neuropathic Pain or Epilepsy? Drug Development Lessons Learned. Keppel Hesselink, JM.[2018]

A structured intervention program for 20 children with central auditory processing disorders (C)APD significantly improved their speech recognition in noisy environments compared to a control group of 10 untreated children, indicating the efficacy of the training.

The training, which included various listening exercises in both quiet and noisy conditions, led to notable improvements in performance for both ears, with specific enhancements observed in the left ear for competing sentence tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of speech in noise and dichotic listening intervention programs on central auditory processing disorders. Putter-Katz, H., Adi-Bensaid, L., Feldman, I., et al.[2019]

Children with auditory processing disorders (APD) showed significant improvements in speech perception and academic performance after using Phonak EduLink FM devices, compared to a control group.

Prolonged use of FM devices not only enhanced speech perception in noisy environments but also led to improved performance even without the devices, indicating potential long-term benefits for the auditory system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiple benefits of personal FM system use by children with auditory processing disorder (APD). Johnston, KN., John, AB., Kreisman, NV., et al.[2015]

The study involving 47 children (21 typically developing and 26 with suspected auditory processing disorder) found no significant differences in sound localization abilities between those with suspected APD and typically developing peers, suggesting that localization difficulties may not be a universal issue in APD.

Both groups showed a significant ability to benefit from spatial release from masking, indicating that children with suspected APD can still effectively separate speech from noise, although some individuals may struggle with localization in certain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Localization and Spatial Release From Masking in Children With Suspected Auditory Processing Disorder. Boothalingam, S., Purcell, DW., Allan, C., et al.[2020]

In a 4-week study involving 105 stable schizophrenia patients, CX516, an AMPA-receptor-positive modulator, did not show any significant improvement in cognitive function compared to placebo, regardless of the antipsychotic treatment (clozapine, olanzapine, or risperidone).

While CX516 was generally well tolerated, it was associated with side effects like fatigue, insomnia, and epigastric discomfort, and it did not outperform placebo in improving schizophrenia symptoms as measured by the PANSS total score.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled add-on trial of the Ampakine, CX516, for cognitive deficits in schizophrenia. Goff, DC., Lamberti, JS., Leon, AC., et al.[2018]

A 12-week computer-based auditory training program significantly improved speech-in-noise perception and functional listening skills in children with auditory processing disorder (APD), with effect sizes ranging from 0.76 to 1.7.

The improvements in speech-in-noise performance were maintained for at least 3 months after the training, indicating the long-term efficacy of the intervention in enhancing auditory processing skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Training Effects on the Listening Skills of Children With Auditory Processing Disorder. Loo, JH., Rosen, S., Bamiou, DE.[2015]

Recent research highlights the potential of glycine(B) site antagonists and NMDA channel blockers as neuroprotective agents for treating neurodegenerative diseases, with several candidates currently in development.

While NMDA receptor antagonists may be beneficial for chronic neurodegeneration, AMPA antagonists appear to be more effective for acute conditions like stroke or trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective potential of ionotropic glutamate receptor antagonists. Danysz, W., Parsons, CG.[2023]

In a study involving patients with moderate to catastrophic chronic subjective tinnitus, BGG492 (selurampanel) significantly reduced tinnitus loudness and annoyance after a single dose, indicating its potential efficacy as a treatment.

After 2 weeks of treatment, a greater proportion of patients showed improvement in tinnitus severity compared to placebo, although dizziness was a common side effect, particularly at the higher dose of 100mg TID.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of single- and repeated-selurampanel dosing for 2 weeks in patients with chronic subjective tinnitus: Results of a randomized, double-blind, placebo-controlled, cross-over, proof-of-concept phase IIa study. Kucher, K., Johns, D., Wagner, F., et al.[2021]

Dizocilpine (DIZO), an NMDA receptor antagonist, significantly impaired maze performance in rats in a dose-dependent manner, particularly affecting cognitive measures like errors and alternation errors, with the highest dose causing severe motor ataxia.

In a delayed-matching-to-sample task, the 0.05 mg/kg dose of DIZO disrupted performance, especially in tasks requiring side changes, indicating that NMDA receptor activity is crucial for certain cognitive functions related to maze navigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NMDA receptor channel antagonism by dizocilpine (MK-801) impairs performance of rats in aversively motivated complex maze tasks. Spangler, EL., Bresnahan, EL., Garofalo, P., et al.[2019]

Citations

1. phonak.com phonak.com/content/dam/phonak/en/evidence-library/journal-article/Experimental_results_on_APD_management_with_personal_FM_systems.pdf

Auditory Processing Disorders II: experimental results on ... The benefits provided by FM systems were estimated to be of approximately +15 dB SNR (Hawkins, 1984) and FM systems have often proven to be much more efficient ...

2. phonakpro.com phonakpro.com/il/en/resources/information-forms/evidence/Library.html

Evidence-Based Research | PhonakPro Phonak puts research at the core of every new product and feature. Browse these resources to learn more about the science behind our technologies.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11224551/

Hearing rehabilitation of adults with auditory processing disorder Our analysis revealed: AT, Mixed results with some improvements in speech intelligibility and listening ability, indicating potential benefits but highlighting ...

4. withpower.com withpower.com/trial/phase-auditory-diseases-central-3-2024-5aaae

Hearing Aids for Central Auditory Processing Disorder The Phonak Lumina P90 hearing aids are unique because they are specifically designed to improve hearing clarity and speech understanding, which may help address ...

5. phonak.com phonak.com/en-us/hearing-devices/hearing-aids/audeo-lumity

Hearing Aids with Improved Speech Understanding Audéo Lumity focuses on giving you improved speech understanding with its unique Phonak SmartSpeech Technology so you can enjoy conversations in many ...

6. phonak.com phonak.com/en-us/hearing-devices/hearing-aids/audeo-lumity/features

Features - Phonak Audéo Lumity hearing aids Key Features: Universal Connectivity, Health data tracking, Rechargeable, Compatibility with myPhonak app, Compatibility with Roger and Phonak wireless ...

7. youtube.com youtube.com/watch?v=uRZRbIo2XmA

NEW Phonak Lumity Detailed Hearing Aid Review ... Phonak Audeo Lumity Detailed Hearing Aid Review | Actual Hands-On Review! · WORST Hearing Aids of 2025 · The BEST Hearing Aid for Tinnitus?

8. phonak.com phonak.com/content/dam/phonak/en/evidence-library/field-studies/PH_FieldStudyNews_LumityBeamformerAdvancements_210x280_EN.pdf

Phonak Field Study News. Results also show a high degree of satisfaction with the Audéo Lumity hearing aids, measured daily over a two-week period. for one ...