A Clinical Investigation of the Benefit of Directionality as a Function of Microphone Location: BTE Hearing Aids Versus ITE Hearing Aids
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- Bernafon AG
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Speech Intelligibility Performance
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Speech Intelligibility Performance
Time Frame: Through study completion, an average of one month.
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.
Word Recognition
Time Frame: Through study completion, an average of one month.
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.
Secondary Outcomes
- Subjective Performance of Aided Benefit(Through study completion, an average of one month.)