A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids

NCT04168229 | Completed

• 1 other identifier: BF003-1808
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The current study will evaluate a new in-the-ear (ITE) hearing aid hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the behind-the-ear (BTE) hardware style with the ITE devices regarding the benefit received from different microphone locations.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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 BTE device, and aided with the new ITE device. The test is the Oldenburg Sentence test (OLSA) and uses nonsense sentences. 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 decibels (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.

  Through study completion, an average of one month.

• Word Recognition

  Word recognition test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the BTE device, and aided with the new ITE device. The test is called the Göttinger sentence test (GÖSA) and uses content relevant sentences that subjects repeat . 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 decibels (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.

  Through study completion, an average of one month.

Secondary Outcomes (1)

• Subjective Performance of Aided Benefit

  Through study completion, an average of one month.

Other Outcomes (2)

• Adverse Events

  Through study completion, an average of one month.

• Unexpected device behavior

  Through study completion, an average of one month

Study Arms (2)

ITE Hearing Aid

EXPERIMENTAL

The subjects will wear the ITE devices in a field test for 10 +/-7 days. At the second and third visits they will perform speech testing in the lab in three randomized conditions (unaided, aided with ITE, and aided with BTE).

Device: Mermaid 9 ITE

BTE Hearing Aid

ACTIVE COMPARATOR

The subjects will wear the BTE devices in a field test for 10 +/-7 days. At the second and third visits they will perform speech testing in the lab in three randomized conditions (unaided, aided with ITE, and aided with BTE).

Device: Mermaid 9 BTE

Interventions

Mermaid 9 ITE DEVICE

A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and receiver housed in an in-the-ear hardware.

ITE Hearing Aid

Mermaid 9 BTE DEVICE

A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and Receiver housed in a behind-the-ear hardware.

BTE Hearing Aid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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
• Current hearing aid users
• Both genders
• Ages 18 and older
• 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
• 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

Study Officials

• Barbara Simon, AuD

  Bernafon AG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Masking is not possible as the differences in hardware between the devices is obvious. The subjects and Investigator will recognize which device is the new one and which is the comparator.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a controlled, open-label, comparative trial using a cross-over design. The subjects first wore the BTE Hearing aids and then the ITE.

Study Record Dates

• First Submitted: November 11, 2019
• First Posted: November 19, 2019
• Study Start: July 12, 2018
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)