Investigating Hearing Aid Frequency Response Curves 2

Overseen ByJinyu Qian, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sonova AG

Disqualifiers: Limited mobility, Abnormal eardrum, others

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

Trial Summary

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 data supports the effectiveness of the treatment Hearing Aid - Standard Curve, Hearing Aid - Variation #1?

Research shows that hearing aids with wide dynamic range compression (WDRC) are generally more effective than linear hearing aids, especially at low speech levels, providing better sound quality and reducing listening effort. Additionally, users report higher satisfaction with hearing aids over time, indicating their effectiveness in improving hearing in various environments.¹ ² ³ ⁴ ⁵

Is the treatment generally safe for humans?

The research does not provide specific safety data for the treatment, but it highlights issues with hearing aid malfunctions and quality, suggesting that improvements are needed to meet reasonable standards.⁶ ⁷ ⁸ ⁹ ¹⁰

How does the Hearing Aid - Standard Curve and Variation #1 treatment differ from other hearing aid treatments?

The Hearing Aid - Standard Curve and Variation #1 treatment may involve unique fitting procedures like the NAL-NL1, which aims to maximize speech clarity while keeping loudness comfortable. This approach differs from others by prescribing less gain for certain hearing loss patterns and using less compression, potentially offering a more tailored hearing experience.⁶ ¹¹ ¹² ¹³ ¹⁴

What is the purpose of this trial?

This trial tests different ways hearing aids process sound to see if users prefer new settings over the current ones. It targets people who use hearing aids to find out if these changes make speech and music clearer and more comfortable. By adjusting how the hearing aid amplifies sounds, researchers aim to improve user satisfaction.

Research Team

Jinyu Qian, PhD

Principal Investigator

Sonova AG

Eligibility Criteria

Inclusion Criteria

N3 - N5 Hearing losses

Healthy Outer ear

No visible congenital or traumatic deformity of the outer ear

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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

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Timeline

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

Treatment Details

Interventions

Hearing Aid - Standard Curve
Hearing Aid - Variation #1

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Participants with Hearing LossExperimental Treatment12 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.