Trial Outcomes & Findings for Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users (NCT NCT04242940)

Race and Ethnicity were not collected from any participant.

Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR a third-order polynomial function was fit to the pupil dilation data, with the OSN setting as a fixed factor, as well as the interaction of OSN with each of the polynomial time terms. The formula used is the following: Pupil Dilation = (Linear + Quadratic + Cubic) X OSN setting + (1 + Linear + Quadratic + Cubic\| Subject); where the Linear, Quadratic, and Cubic are the orthogonal terms; X indicates the interaction with OSN setting, and the terms reported in the second parenthesis are the random factors. The random factors include the effect of listeners, and of each of the time terms, to account for the variability in the time course of dilation across listeners. Outcome measure is the percentage reduction(% change) in pupil dilation with OSN ON vs OSN OFF

The difference in pupil dilation between OSN ON and OSN OFF was also analyzed via Peak Pupil Dilation (PPD); thus, by investigating differences in dilation at the peak of the curve. The PPD was obtained for each subject as the maximum dilation between 7.5 and 9 s.

A mixed-linear model with OSN setting (2 levels: ON and OFF) and SNR (5 levels: -8, -4, 0, +4, +8 dB) as fixed factors, and subject as random factor, was fit to the data.

Self-reported perception before, during (at 1 month), and after field trial (at 3months). The SSQ questionnaire consists of 49 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". The SSQ questionnaire is comprised of three subscales domains (Speech, Spatial, and Qualities of Hearing) - that is, each of the 49 items fits into one of these subscale "categories". The subscale scores AND the total scores (the total score is comprised of all of the 49 items) use the same scale of 0 to 10 where 0 represents "Not at all" and 10 represents "Perfect". For the total scale and all subscales (again all questions and by extension, the scales range from 0 to 10) the higher the value (closer to 10) represents a better outcome than lower values (closer to 0).

Self-reported preference after field trial. The preference questionnaire consists of 11 questions. The scores are from 1 to 5, where 1 means "Own sound processor much better" and 5 means "Test sound processor \[Ponto 4\] much better".

Sound field audiometry performed with the Auricle system while the patient is wearing the Ponto sound processor. This measurement is conducted at 10 frequencies from 250 Hz to 8 kHz. The Pure tone threshold is calculated as the average across .5, 1, 2, \& 3 kHz)

Hearing level thresholds (dB HL) as assessed in situ with Ponto 4 placed on the patient's abutment. Bone-conduction thresholds (BC) are measured as the softest sound level that is audible by the patient at 10 frequencies from 250 Hz to 8 kHz. The Pure tone threshold is calculated as the average across .5, 1, 2, \& 3 kHz

Self-reported work-related fatigue. The NFR scale is an 11-item scale assessing the effects of fatigue caused by work (e.g., " I find it hard to relax at the end of a working day"). Possible responses are "yes" or "no". The total NFR score is the number of "yes" responses divided by the total number of items, presented as a percentage (i.e., range 0-100). The higher the score, the greater the NfR felt by the respondent. Scores with own device compared with Ponto 4 after 3months field trial are reported.

Change in pupil dilation after field trial to check for acclimatization effects. Comparison of speech recognition scores for OSN Auto and OSN OFF at start and end of field trial.