Hearing Loss
Conditions
Brief summary
In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.
Interventions
DEVICEMeasures of Standard Noise Reduction NR1
Each participant will be fitted with the Standard Noise Reduction (NR1)
DEVICEMeasures of Noise Reduction Principle NR2
Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid
DEVICEMeasure of Noise Reduction Principle NR3
Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid
Sponsors
Sonova AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Minimum age for men: 18 years, minimum age for wom-en: 64 years, hearing aid users, * Written and spoken German, * Hearing loss range: N3-N4 Hearing loss (sensorineural) * Healthy outer ear, * Ability to understand and follow the instruction of the in-vestigator * Informed consent as documented by signature.
Exclusion criteria
* Clinical contraindications 1) hearing loss is not within the fitting range of the hearing aid, 2) acute tinnitus, 3) de-formity of the ear (closed ear canal or absence of pinna), and 4) neural hearing loss i.e., retro-cochlear pathologies such as absent / non-viable auditory nerve * Pregnant or breastfeeding women * Age \>85 years * known hypersensitivity or allergy, * limited mobility and not able to attend the appointments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in speech reception thresholds (SRTs) in noise between novel noise reduction algorithm (NR2) and the standard noise reduction (NR1; Comparator) | 4 weeks | SRTs are measured with the OLSA test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation whether the novel noise reduction algorithm (NR3) provides different SRTs in noisy situation with speech from front compared to the current implemented standard noise reduction (NR1; Comparator) | 4 weeks | SRTs are measured with the OLSA test. |
| Evaluation of subjectively different sound quality attributes/dimensions of the novel noise reduction algorithms versus standard noise reduction (Comparator) | 4 weeks | The sound quality ratings will be assessed with the aid of a Multi-Stimulus Test. |
Countries
Germany
Outcome results
None listed