A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid

NCT03086018 | Completed Results

• 1 other identifier: BF001-1611
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already available on the market. The hearing aids are adapted according to the user requirements. The data collected in the study is intended to show that the benefit of the hearing aid being examined is identical or better than the current CE-marked hearing aid. A further aim is to improve the adaptation of the hearing device in such a way that the benefit for people with hearing impairments can be increased.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• Speech Intelligibility Performance

  Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the current device, and aided with the new device. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 dB and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.

  2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

Secondary Outcomes (4)

• Subjective Performance of Aided Benefit

  A 2 week time period during which they will wear the devices and answer questionnaires about the experience.

• Speech Intelligibility Performance With New Feature

  2 hour period of speech testing during a lab appointment after wearing the devices for approximately 2 weeks.

• Handling/Usability Performance

  2 hour period of usability testing with tasks and questionnaires.

• Events

  A 2 hour period of interviews and questionnaires after having worn the devices for approximately 2 weeks and keeping a diary to make notes of device behavior.

Study Arms (1)

Successor hearing aid to Juna

EXPERIMENTAL

The intervention is the new device which is the successor to the Juna device. The participants will use their current device as a control. The will wear the intervention device for approximately two weeks.

Device: Successor hearing aid to Juna

Interventions

Successor hearing aid to Juna DEVICE

The participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device.

Successor hearing aid to Juna

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All classifications of hearing loss (sensorineural, conductive, mixed)
• If the hearing loss is conductive or mixed it must be approved for amplification by a physician
• All shapes of hearing loss (flat, sloping, reverse slope, notch)
• Severity ranging from mild to severe
• German speaking
• Ability and willingness to sign the consent form

You may not qualify if:

• Contraindications for amplification
• Active ear disease
• Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant,
• A reduced mobility making them unable to attend weekly study appointments
• A reduced ability to describe auditory impressions and the usage of the hearing aids
• Uncooperative so that it is not possible to record a valid pure tone audiogram
• A strongly reduced dexterity
• Central hearing disorders
• Bernafon employees
• Family members of Bernafon employees

Sponsors & Collaborators

• Bernafon AG: lead

Study Sites (1)

Bernafon AG

Bern, 3018, Switzerland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Julie Tantau
• Organization: Bernafon AG

juta@bernafon.com

+41 31 998 1646

Study Officials

• Barbara Simon, AuD

  Bernafon AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The hardware will be obviously different from the control devices and impossible to blind.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single group, controlled test design will be used. There are various aspects of testing including lab and field tests.

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 22, 2017
• Study Start: March 13, 2017
• Primary Completion: June 28, 2017
• Study Completion: June 28, 2017
• Last Updated: November 6, 2019
• Results First Posted: November 6, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)