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

NCT07388784 — Not applicable, Terminated, 14 participants, Sebastian Griepentrog

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07388784
Status	Terminated - Despite heavy recruiting efforts not enough participants could be found
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: single, treatment
Enrollment	14 (Actual)
Sponsor	Sebastian Griepentrog (Industry)
Conditions	Hearing Loss
Interventions	Competitor device, hearing aid with standard gain precalculation principle, Hearing aid with gain precalculation principle 1, Hearing aid with gain precalculation principle 2 (Device)
Dates	start 2026-04-20, primary completion 2026-07-22, completion 2026-07-22, first posted 2026-02-05, last updated 2026-07-27
Locations	1 site in Switzerland

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Competitor device, hearing aid with standard gain precalculation principle	Active comparator	Device: Hearing aid with gain precalculation principle 1; Device: Hearing aid with gain precalculation principle 2	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	Experimental	Device: Competitor device, hearing aid with standard gain precalculation principle	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	Experimental	Device: Competitor device, hearing aid with standard gain precalculation principle	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.

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.

+Outcome measures

Primary outcomes

Speech intelligibility [From enrollment to the end of treatment at 3 weeks]: Speech intelligibility in % will be assessed with a monosyllabic word recognition test for each of the interventional conditions

Secondary outcomes

Qualitative ratings on naturalness [From enrollment to the end of treatment at 3 weeks]: Sound Signals will be rated in terms of naturalness on a scale from 0 - 100 in increments of 1 for each interventional condition
Qualitative ratings on loudness [From enrollment to the end of treatment at 3 weeks]: Sound Signals will be rated in terms of perceived loudness on a scale from 1 - 5 in increments of 1 for each interventional condition
Qualitative ratings on own voice quality [From enrollment to the end of treatment at 3 weeks]: Own voice will be rated in terms of perceived bothersomeness on a scale from 1 - 5 in increments of 1 for each interventional condition

+Eligibility

Sex: All, ages: 18 Years to 99 Years

Inclusion Criteria:

* 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
* Ability to describe listening impressions / experiences
* Audiogram is in the fitting range of the hearing aids

Exclusion Criteria:

* 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
* Asymmetrical hearing loss
* Hypersensitivity or allergy against synthetic materials
* Symptoms of vertigo or dizziness
* Suffering from any otologic disease

+Locations (1)

Facility	City	Country	Status
Sonova AG	Stäfa	Switzerland

+Investigators

Josephine Hollenbach, Principal investigator, Sonova AG

My Notes

Public

To Read Reading Read