Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.

Time frame: Baseline to Twelve Months

Population: Speech recognition in noise was measured with the AZBio Speech test presented with the participant at 0° and noise was presented from either 90° or 270° dependent on the contralateral ear side. Higher percentages score represents a better ability to identify speech source location.

The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. The intent is to understand the benefit of the implant treatment option and restoration of auditory input results in improved speech understanding.

Time frame: Baseline and Twelve months

Population: The primary outcome measure used in this clinical feasibility study was monosyllabic word recognition with the ear to be implanted in quiet using the CNC word test. Subjects that achieved a CNC word recognition score ≤ 30% in the implanted ear and \>30% in the contralateral ear. Subjects are tested using their everyday listening condition for each ear.

Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.

Time frame: Baseline and Twelve months

Population: Lateralization ability was measured as the ability to identify the location of a sound presented from a loudspeaker placed at +/- 45° in front of the subject. Test is performed using the participant's bilateral, everyday listening condition using both ears and reported for all subjects at baseline compared to month12.

AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.

Time frame: Baseline and Twelve months

Population: Speech recognition in noise was measured with the AZBio speech perception test presented in a background of noise in which the target remained at 0° and noise was presented from 0° (speech front).

AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.

Time frame: Baseline to Twelve Months

Population: Speech recognition in noise was measured with the AZBio Speech test presented with the participant at 0° and noise was presented at either 90° or 270° dependent on the implanted ear side.

Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary. • Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.

Time frame: Baseline and Twelve months

Population: Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary.~• Unaided air conduction thresholds using insert earphones at octave frequencies were measured for non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.