Clinical trial NCT04168229: A Clinical Investigation of the Benefit: BTE Hearing Aids Versus ITE Hearing Aids
Official title: A Clinical Investigation of the Benefit of Directionality as a Function of Microphone Location: BTE Hearing Aids Versus ITE Hearing Aids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Bernafon AG
Sponsor class: INDUSTRY
First posted: 2019-11-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Hearing aids constantly undergo incremental improvements from already marketed devices. The new devices are expected to perform as well or better than the previous ITE devices.

The aim of the testing is to grant quality control prior to product launch according to Bernafon development requirements.

The current study will evaluate a new ITE hearing aid hardware. The firmware driving the hearing aid has already been sold on the market using the BTE hardware for almost one year and will now be launched using the ITE custom 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 two hardware styles regarding the benefit received from different microphone locations.

As human subjects are involved the validation falls under the definition of a clinical investigation. The validation will address the performance of the new chip using the ITE hardware, and ensure that there is no reduction in speech understanding between using the BTE and ITE hardware styles. Evaluating the overall performance of the Mermaid 9 ITE devices is important to validate that the end user is satisfied with the devices and that all user requirements are fulfilled. All features available in Mermaid 9 have been validated and are currently used on the market in Mermaid 9 BTE devices.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Speech Intelligibility Performance
timeFrame: Through study completion, an average of one month.
measure: Word Recognition
timeFrame: Through study completion, an average of one month.
Secondary outcomes:
measure: Subjective Performance of Aided Benefit
timeFrame: Through study completion, an average of one month.
Other outcomes:
measure: Adverse Events
timeFrame: Through study completion, an average of one month.
measure: Unexpected device behavior
timeFrame: Through study completion, an average of one month
Locations:
city: Bern
country: Switzerland
facility: Bernafon AG
Study officials:
affiliation: Bernafon AG
name: Barbara Simon, AuD
role: PRINCIPAL_INVESTIGATOR
References: