Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

Functional gain is the difference between the average unaided threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz and the average aided (i.e. with the Ponto 3 SuperPower) threshold measured across the frequencies of 500, 1000, 2000 and 4000 Hz. For bilaterally fitted patients, the best ear is selected.

Time frame: Visit 2, 3 months

Population: Measurement not applicable for Target Population 3 - SSD

The difference between masked (if not available unmasked) BC and AC thresholds (unaided), denoted 'air to bone gap', calculated for frequencies 500, 1000, and 2000 Hz for the patients with CHL/MHL within indication on the implanted ear. For bilateral patients, the best ear was selected. Only participants that had complete data for these frequencies were included in the analysis.

Time frame: Visit 1 day 1

Population: This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.

Effective gain with Ponto 3 SuperPower, i.e. the difference between aided sound field thresholds and the BC In-situ thresholds on the aided ear(s) measured when the Ponto 3 SuperPower(s) was fitted. The effective gain is calculated as the average (PTA4) of frequencies 500, 1000, 2000 and 4000 Hz. Only participants with data for both study visits were included in the analysis.

Time frame: visit 2, 3 months

Population: Analysis includes tested frequencies. This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.

Functional gain with Ponto 3 SuperPower, i.e. the difference between average unaided AC thresholds and aided sound field thresholds for frequencies 500, 1000, 2000, 3000 and 4000 Hz. For bilaterally fitted patients, the best ear is selected.

Time frame: Visit 1, Day 1

Population: This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.

Aided speech recognition (% correct words) measured in quiet and in noise with the BKB sentence test and the AB\[s\] short list test averaged across patients. Only participants with data for both visits were included in analysis.

Time frame: Visit 2, 3 months

Population: Participants with speech recognition scores recorded included in analysis speech recognition scores. This variable is specific for patients with CHL/MHL only and thus not applicable for those with single-sided deafness, i.e., Target Population 3 - SSD.

Improved hearing was analyzed as the percentage of subjects whose performance is better or equal in the unaided to aided comparisons, i.e., have a difference ≥0. Functional gain was used for CHL/MHL patients and speech recognition in noise was used for SSD patients.

Time frame: Change between visit 1 (day 1) and visit 2 (3 months)t of study

Population: Functional gain for CHL/MHL based on PTA4 was not available for all individuals. Speech recognition in noise was measured aided and unaided for only one SSD patient within indication (TP3 - SSD).

Glasgow Benefit Inventory (GBI) total score per target population. The GBI consists of 18 items, each on a 5 point Likert scale. Responses are scaled and averaged to give a score with a range -100 (poorest outcome) through 0 (no change) to +100 (best outcome).

Time frame: Visit 2, 3 months

Skin condition around the abutment was assessed via Holgers score (scale 0-4). Holgers 0: No skin reaction Holgers 1: Redness with slight swelling Holgers 2: Redness, moistness, and moderate swelling Holgers 3: Redness, moistness, and moderate swelling with tissue granulation Holgers 4: Profound signs of infection, resulting in removal of the implant Only participants who had recorded Holgers score in record were analyzed.

Time frame: Visit 2, 3 months

Population: For Target Population 2 - Bilateral both treated ears are considered.

Difference in speech recognition score (%) for speech recognition in noise between unaided and aided when speech is directed to the aided ear, and noise is directed to the non-implanted ear, and when speech is directed to the non-implanted ear, and when noise is directed to the aided ear. Aided and unaided speech recognition (% correct words) measured with the AB\[s\] short list.

Time frame: Visit 2, 3 months

Population: The aided condition was obtained from two patients while the unaided condition was measured for one patient from the SSD patients within indication (TP2 - SSD, n=3). This outcome is only applicable for Target Population 3 - SSD.