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Investigating Hearing Aid Frequency Response Curves 2

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Sonova

Status

Completed

Conditions

Hearing Loss, Bilateral
Hearing Loss, Sensorineural

Treatments

Other: Hearing Aid - Standard Curve under Program 1
Other: Hearing Aid - Variation #1 under Program 3
Other: Unaided
Other: Hearing Aid - Standard Curve under Program 3
Other: Hearing Aid - Variation #1 under Program 4
Device: Hearing Aid - Variation #1 under Program 1
Other: Hearing Aid - Variation #1 under Program 2
Other: Hearing Aid - Variation #3 under Program 5 - Streaming Only
Other: Hearing Aid - Standard Curve under Program 2
Other: Hearing Aid - Variation #2 under Program 5 - Streaming Only
Other: Hearing Aid - Variation #4under Program 5 - Streaming Only
Other: Hearing Aid - Standard Curve under Program 4

Study type

Interventional

Funder types

Industry

Identifiers

NCT05828017
SRF-12972

Details and patient eligibility

About

Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. Based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. 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 users prefer the variations over the manufacturer's standard curve.

Full description

Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality and listener comfort. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music and while in different listening enviroments.

Enrollment

25 patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • N3 - N5 Hearing losses
  • Healthy Outer ear
  • No visible congenital or traumatic deformity of the outer ear
  • Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
  • Ability to answer questions and repeat sentences
  • No history of problematic tinnitus or pain/discomfort from loud sounds
  • No history of active drainage from the ears in the past 90 days
  • Willingness to wear different styles of couplings
  • Willingness to wear binaural fitting
  • Experienced Users = more than 3 months of hearing aid experience
  • Ability to travel to Sonova facilities

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
  • History of active drainage from the ear in the previous 90 days
  • Abnormal appearance of the eardrum and ear canal.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Participants with Hearing Loss
Experimental group
Description:
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.
Treatment:
Other: Hearing Aid - Standard Curve under Program 4
Other: Unaided
Other: Hearing Aid - Variation #4under Program 5 - Streaming Only
Other: Hearing Aid - Variation #2 under Program 5 - Streaming Only
Other: Hearing Aid - Standard Curve under Program 2
Other: Hearing Aid - Variation #3 under Program 5 - Streaming Only
Other: Hearing Aid - Variation #1 under Program 2
Other: Hearing Aid - Variation #1 under Program 3
Other: Hearing Aid - Variation #1 under Program 4
Device: Hearing Aid - Variation #1 under Program 1
Other: Hearing Aid - Standard Curve under Program 1
Other: Hearing Aid - Standard Curve under Program 3

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Bilal Sheikh, MClSc-Aud; Jinyu Qian, PhD

Data sourced from clinicaltrials.gov

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