Hearing Aids for Hearing Loss

Overseen By Jinyu Qian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonova AG

Disqualifiers: Limited mobility, Abnormal eardrum, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different frequency settings in hearing aids can enhance user satisfaction. Participants will test two settings: the standard one (Hearing Aid - Standard Curve) and a new variation (Hearing Aid - Variation #1). The trial seeks individuals with long-term hearing loss who wear hearing aids and can visit Sonova facilities. Participants should be comfortable trying different hearing aid styles and have no significant ear issues, such as frequent drainage or discomfort from loud sounds. As an unphased trial, this study offers a unique opportunity to contribute to advancements in hearing aid technology and improve user experiences.

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 hearing aid frequency response curve is safe for users?

Research has shown that hearing aids, like those in this study, are generally safe for users. One study found that when hearing loss exceeds 60 decibels, small changes in hearing might occur with hearing aid use, but these changes remain safe. Another source mentioned that about 1 in 100 hearing aid users might encounter safety concerns.

Reports for the type of hearing aid being tested show very few problems. Some issues could arise from the device's construction, such as parts coming loose, but these are rare. Overall, hearing aids have a good safety record, and most users do not experience significant problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these hearing aids because they explore different frequency response curves, which could significantly enhance hearing experiences for those with hearing loss. Unlike standard hearing aids that generally follow a set frequency response curve, these new options offer a variation that might better match the individual hearing profiles of users. This personalized approach could lead to improved clarity and comfort, making daily listening experiences more natural and enjoyable.

What evidence suggests that these hearing aid frequency response variations could be effective for hearing loss?

Research has shown that hearing aids with wide dynamic range compression (WDRC) generally outperform linear hearing aids, particularly for understanding quiet conversations. For standard hearing aids, strong evidence does not support that expensive features significantly enhance results compared to basic models. In this trial, participants will be assessed using both the Hearing Aid - Standard Curve and Hearing Aid - Variation #1. Studies indicate that results for Hearing Aid - Variation #1 can vary significantly, especially at different sound levels like 55 dB and 65 dB. Overall, while both options have potential, their effectiveness can depend on the specific features and settings used. ^{1 6 7 8 9}

Who Is on the Research Team?

Jinyu Qian, PhD

Principal Investigator

Sonova AG

Are You a Good Fit for This Trial?

Inclusion Criteria

N3 - N5 Hearing losses

Healthy Outer ear

No visible congenital or traumatic deformity of the outer ear

Exclusion Criteria

Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)

Limited mobility/not able to come to the scheduled visit

Inability to produce reliable hearing test results

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants compare the manufacturer's current frequency response curve to variations and determine preferences in different listening environments.

1-2 weeks

Multiple sessions in a sound booth

Follow-up

Participants are monitored for feedback on hearing aid performance and satisfaction.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Hearing Aid - Standard Curve
• Hearing Aid - Variation #1

How Is the Trial Designed?

Group I: Participants with Hearing Loss Experimental Treatment 12 Interventions

Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.

Who Is Running the Clinical Trial?

Sonova AG

Lead Sponsor

Trials

84

Recruited

2,000+

Arnd Kaldowski

Sonova AG

Chief Executive Officer since 2018

MBA from INSEAD, MSc in Mechanical Engineering from ETH Zurich

Stefan Launer

Sonova AG

Chief Medical Officer since 2016

PhD in Natural Sciences from ETH Zurich

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05828017

Investigating Hearing Aid Frequency Response Curves 2 This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12360717/

Predicting Hearing Aid Outcomes Using Machine Learning This study explores and classifies the predictive factors of HAs outcomes, looking at the impact of HA technology, personalized adjustments made by the hearing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4925253/

Impact of Hearing Aid Technology on Outcomes in Daily Life I In the current research, there was no evidence to suggest that premium-feature devices yielded better outcomes than basic-feature devices from the patient's ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05521308

Investigating Hearing Aid Frequency Response Curves This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid ...

5. withpower.com withpower.com/trial/phase-hearing-loss-4-2023-05d24

Investigating Hearing Aid Frequency Response Curves 2 Research shows that hearing aids with wide dynamic range compression (WDRC) are generally more effective than linear hearing aids, especially at low speech ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3876025/

Hearing aid safety: a comparison of estimated threshold ... When hearing loss exceeds 60 dB HL, small amounts of ATS can be expected to occur during hearing-aid use, but these amounts are safe for hearing thresholds up ...

7. osha.gov osha.gov/otm/section-3-health-hazards/chapter-5

OSHA Technical Manual (OTM) - Section III: Chapter 5 Conductive hearing loss may be reversible through medical interventions such as hearing amplification (e.g. hearing aids) or surgical treatment.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1808869415306467

The noise spectrum influence on Noise-Induced Hearing ... The audiometries with scores suggesting Noise Induced Hearing Loss were the ones with normal reports and a notch in the frequencies of 3,000 Hz, 4,000 Hz, 6,000 ...

9. downloads.regulations.gov downloads.regulations.gov/FDA-2021-N-0555-1143/content.pdf

Safety limit warning levels for the avoidance of excessive ... Macrae (1985) had indicated concern for safety was on the order of 1 out of 100 for individuals wearing hearing aids.