Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO

The Oldenburg Sentence Test (OLSA) is an audiometric test for determining the speech recognition threshold (SRT in dB). 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. For this study speech in noise recognition was measured. Noise level was 65 dB SPL played from the back, speech was presented from front. The SRT shows the signal-to-noise ratio needed for 80% speech recognition. Lower values mean better speech understanding (i.e. the speech can be quieter with respect to the noise and still be understood). There are no minimum or maximum values.

Time frame: 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. Results are reported in Percent correct data. Minimum is 0%, maximum is 100% with higher values meaning better speech understanding.

Time frame: Estimated Time Frame 2 weeks (Test conducted at second lab session).

Investigate outcomes and effectiveness of hearing aid usage in real-life. Responses are given on a scale from 1 - 5. Here, the mean of questions 2 -7 is reported. Higher values represent better outcomes. Question 1 was on wearing time, which is not considered a rating of effectiveness and was therefore excluded from the mean and will be reported separately. Fpr wearing times higher values represent longer wearing time (maximum 5 equals more than 8 hours a day).

Time frame: 2 weeks

Population: The IOI-HA was developed to measure outcomes in audiological rehabilitation using Hearing Aids and is not designed for the unaided condition. For this reason only the two interventional arms are included for this outcome measure.

Investigate how close the study hearing aids fitted and fine-tuned with the fitting software to NAL-NL2 Targets match the postulated targets, as measured in-situ with real-ear measurements. Absolute deviations were calculated at specific frequencies ranging from 250 Hz to 4 kHz. Unit of measure is dB SPL. Minimum Value is 0 (i.e. measured value and target value identical), no maximum value. Higher values mean greater deviation from target.

Time frame: 1 day (Fitting procedure with real-ear measurements is done at first lab session)

Investigate satisfaction in real-life for different aspects such as sound quality, naturalness of sound, conversation with one person and overall satisfaction. Each aspect was assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied) The overall satisfaction and sound quality overall were individual questions and are not the combination of different situations/aspects. These questions were also assessed on on a 7-point likert scale, going from 1 (very dissatisfied) to 7 (very satisfied). Higher values represent better outcomes.

Time frame: 2 weeks

Population: The satisfaction questionnaire was developed to measure satisfaction with hearing aids and not designed for the unaided condition. For this reason data was only collected for the two interventional arms.

A short form of the SSQ is used (SSQ 17, German version), to investigate speech perception, sound localisation, quality of hearing perceived in real-life. Questions are answered on a scale from 0 to 10, higher scores mean better outcomes. The responses to the individual questions are grouped for the subsections (speech, spatial, quality) by calculating the means.

Time frame: 2 weeks

Population: The aim of the SSQ questionnaire was to compare the performance/benefit of the study hearing aids to the subjects' own devices. As the unaided ratings would have been the same for both arms, they would have cancelled out by comparing the two interventions and thus it was considered as not necessary to collect the unaided responses.