The study is a prospective, single-center, comparative, cross-over study with within-subject
      control design. In the investigation an updated sound processor will be tested at compared to
      the CE marked Ponto 3 SuperPower sound processor (available on the market since December
      2016) in order to establish marketing claim(s) on the updated sound processor.

      The performance of the two sound processors will be evaluated via speech and hearing tests,
      and patient reported outcomes.

Investigation of an Updated Bone-anchored Sound Processor

Hearing Loss

Hearing Loss, Conductive

Hearing Loss, Mixed

Hearing Disorders

Deafness

Ear Diseases

Otorhinolaryngologic Diseases

Sensation Disorders

Neurologic Manifestations

Nervous System Diseases

The investigation is a premarket investigation with the purpose of gathering knowledge on the
      performance of an updated sound processor compared to the CE marked Ponto 3 SuperPower sound
      processor to establish marketing claim(s) on the updated sound processor.

      The recruitment for this clinical investigation will be performed among subjects who have
      already received a Ponto 3 SuperPower sound processor as a minimum three month prior to the
      study. 12-15 adult Ponto 3 SuperPower users with a conductive, mixed hearing loss or
      single-sided deafness will be included.

      The study is a prospective, single-center, comparative, cross-over study with within-subject
      control design. The study includes four laboratory visits and three field trial periods.
      After the first trial period, which is included to ensure a homogenous baseline, the study is
      designed as a two-period, two-sequence crossover trial to compare the two sound processors
      (Device A & Device B). Each participant is randomized into one of two sequences: (1) Device A
      then B, or (2) Device B then A, such that (about) half of the participants are assigned to
      one sequence and the other half to the second sequence.

      This study is designed to combine audiological assessments (hearing and speech tests) in the
      laboratory and subjective self-reported outcomes collected during and after field trial
      periods with the investigational device and the comparator device (Ponto 3 SuperPower). The
      primary outcome of this study is to demonstrate that Open Sound Navigator in the updated
      sound processor provides subjects with improved speech recognition in noise.

Device A

Device B

BC109 - Investigation of an Updated Bone-anchored Sound Processor

Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between OSN OFF and OSN ON after field trial with Device A (incl. automatics).

Percentage (%) of subjects who prefer Device A over Device B in noisy sound environments.

Functional gain with Device A, i.e. the difference in dB between unaided and aided sound field thresholds, for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Functional gain with Device A, see definition above, calculated on average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).

Effective gain defined as the difference in dB between aided sound field thresholds with Device A, and BC in-situ thresholds on the aided ear(s). The effective gain is calculated for frequencies 250, 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Effective gain with Device A, see definition above, calculated in average for frequencies 500, 1000, 2000 and 4000 Hz (PTA4).

Difference in speech recognition score in percent between unaided and aided, assessed in quiet on the aided ear(s).

Difference in SRT70 between Device A and Device B in Omni settings as measured at Visit 1.

Difference in signal-to-noise ratio at 70% correct (referred to as SRT70) between Omni and Full Dir after field trial with Device B.

Comparison of the difference in SRT70 between OSN OFF vs. OSN ON in Device A and Omni vs. Full Dir in Device B.

Average SSQ12 scores with Device A for each question, sub-scales and in total.
Average SSQ12 scores with Device B for each question, sub-scales and in total.
Difference in SSQ12 scores between Device A and Device B for each question, sub-scales and in total.

Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 1. field trial with Device A as obtained via phone interview
Average ratings with Device A for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device A
Average ratings with Device B for each question of the "SPSK sound quality" questionnaire completed during the 2. or 3. field trial with Device B
Difference in ratings between Device A and Device B for each question of the "SPSK sound quality" questionnaire
Average ratings with Device A for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device A
Average ratings with Device B for each question of the "SPSK situations" questionnaire completed during the 2. or 3. field trial with Device B
Difference in ratings between Device A and Device B for each question of the "SPSK situations" questionnaire

Difference in dB between BC in situ thresholds and BC thresholds measured with conventional BC audiometry.

Difference in dB between BC in situ thresholds measured with Device A and Device B.

Tabulated adverse events and serious adverse event related to the Device A reported throughout the study.

Starts with Device A in first and second trial period and change to Device B in third trial period.

Starts with Device A in first trial period, wears Device B in second trial period and change to Device A in third trial period.

Investigation of an Updated Bone-anchored Sound Processor

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status