Hearing Loss, Sensorineural
Conditions
Keywords
Hearing aid, Freiburger, Matrix Test
Brief summary
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.
Detailed description
This is a comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test a released hearing aid and compare this to the subject's own hearing aids with a minimum of 18 adult subjects with mild-to-moderate sensorineural hearing impairement. The subjects, all native German speakers, have 1 appointment of 1-2 hours including a fitting procedure with real-ear measurements and selected standard speech tests and tests of basic hearing-aid related task.
Interventions
DEVICEIn-the-Ear Hearing Aid
Custom In-the-Ear hearing aid. Form Factor In the Canal (ITC)
DEVICEOwn hearing aid
subjects' own hearing aids, any brand, any model
Sponsors
WSAUD A/S
Hoerzentrum Oldenburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sensorineural hearing loss, mild-to-moderately severe (Pure tone average of 500, 1000, 2000 and 4000 Hz \<65). * Hearing loss should fall within fitting range of study hearing aid * Subjects should be experienced hearing aid users who have had and used hearing aids daily for at least 1 year. * Air-Bone-Gap should be less or equal to 20 dB. * Asymmetry between left and right ear should not exceed 20dB for frequencies in the range of 250Hz to 4kHz * Healthy (outer and middle) ear * Older than 18 years * German is mother tongue * Able to understand the instructions * Willing to participate in laboratory tests and to wear the study HAs at home for 2 weeks * Informed consent
Exclusion criteria
* Contraindication for HA treatment * Fluctuating or rapidly progressing hearing loss * "Central" hearing problems * Limited mobility * Limited dexterity (in handling the HA) * Known psychological or cognitive problems * Subjects must not show any injuries or a complete perforation of the ear drum. This must be clarified prior to the beginning of the study by means of otoscopy. * Subjects should be in good overall medical condition (e.g., they shall not suffer from dementia) and should not use medical treatments that might affect study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oldenburg Sentence Test | Estimated Time Frame 2 weeks (Test conducted at second lab session). | The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold in quiet and in noise. Sentences of the form name - verb - numeral - adjective - noun are used as speech material. The sequence of words is a random combination from an inventory of 50 words in total. The design of the test prevents memorization of the sentences, so the OLSA can be repeated as often as desired. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freiburger Monosyllabic Speech Test | Estimated Time Frame 2 weeks (Test conducted at second lab session). | To investigate speech intelligibility (SI) performance for speech at 65dB in a quiet listening situation, the Freiburger monosyllabic speech test is used which is still the gold standard for Hearing Care Professionals (HCPs) in Germany. |
| Match-to-Target | Day 1 (Fitting procedure with real-ear measurements is done at first lab session) | Investigate how close the study hearing aids fitted with the fitting software to NAL-NL2 Targets match the postulated targets, as measured in-situ with real-ear measurements |
| Basic user need documentation | One session of approximately 2 hours. | Investigate ability to carry out different hearing-aid related tasks with the test hearing aids documenting if the subjects can carry out the task without support / with support of IFU / with support of Audiologist / Not at all. |
Countries
Germany
Outcome results
None listed