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Exploration of the Functional Effect of Modified Gain Precalculation on Soft Speech Intelligibility

ConditionHearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorSebastian Griepentrog

About this trial

An exploratory investigation of gain precalculation principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These gain precalculation principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and assess strength and weaknesses of these gain precalculation principles in terms of speech intelligibility to determine their application in hearing instruments (Phase of development). Objective laboratory measurements as well as subjective ratings will be carried out. This will be a controlled, single blinded and randomized active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Hearing impaired adult at a minimum age of 18 years

Good written and spoken german skills

Ability to fill in a questionnaire concientiously

Ability to produce a reliable hearing test result

Disqualifiers

Unaidable hearing loss in one or both ears

Auricle deformities that prevent secure placement of the investigational device

Acute tinnitus in one or both ears

Unwillingness to test the investigational device

Trial design

Design model

Crossover

Treatments tested in this trial

  • Competitor device, hearing aid with standard gain precalculation principle

    Device

    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The active comparator condition is the state of the art hearing aid gain precalculation from a competitor device.

  • Hearing aid with gain precalculation principle 1

    Device

    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.

  • Hearing aid with gain precalculation principle 2

    Device

    Each participant will be fitted with two different pairs of hearing aids with different gain precalculation principles. Gain precalculation applies the amplification of sound signals in the hearing aid. The experimental conditions vary in their parametrization to result in different degrees of added amplification.

Treatment groups

16 Participants
are divided into 3 treatment groups
Group A: Competitor device, hearing aid with standard gain precalculation principleActive comparator 2 interventions
Group B: Hearing aid with gain precalculation principle 1Experimental treatment 1 intervention
Group C: Hearing aid with gain precalculation principle 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Speech intelligibility

Speech intelligibility in % will be assessed with a monosyllabic word recognition test for each of the interventional conditions

Time frame
From enrollment to the end of treatment at 3 weeks

Secondary outcomes

1

Qualitative ratings on naturalness

Sound Signals will be rated in terms of naturalness on a scale from 0 - 100 in increments of 1 for each interventional condition

Time frame
From enrollment to the end of treatment at 3 weeks
2

Qualitative ratings on loudness

Sound Signals will be rated in terms of perceived loudness on a scale from 1 - 5 in increments of 1 for each interventional condition

Time frame
From enrollment to the end of treatment at 3 weeks
3

Qualitative ratings on own voice quality

Own voice will be rated in terms of perceived bothersomeness on a scale from 1 - 5 in increments of 1 for each interventional condition

Time frame
From enrollment to the end of treatment at 3 weeks

Other outcomes

Sponsors and contacts

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Sebastian Griepentrog

Lead sponsor

Sonova AG

Sponsor institution

Source ClinicalTrials.gov
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