Safety and effectiveness of the Bonebridge transcutaneous active direct-drive bone-conduction hearing implant at 1-year device use

A large set of sentence materials, chosen for their uniformity in length and representation of natural speech, has been developed for the measurement of sentence speech reception thresholds (sSRTs). The mean-squared level of each digitally recorded sentence was adjusted to equate intelligibility when presented in spectrally matched noise to normal-hearing listeners. These materials were cast into 25 phonemically balanced lists of ten sentences for adaptive measurement of sentence sSRTs. The 95% confidence interval for these measurements is +/- 2.98 dB for sSRTs in quiet and +/- 2.41 dB for sSRTs in noise, as defined by the variability of repeated measures with different lists. Average sSRTs in quiet were 23.91 dB(A). Average sSRTs in 72 dB(A) noise were 69.08 dB(A), or -2.92 dB signal/noise ratio. Low-pass filtering increased sSRTs slightly in quiet and noise as the 4- and 8-kHz octave bands were eliminated. Much larger increases in SRT occurred when the 2-kHz octave band was eliminated, and bandwidth dropped below 2.5 kHz. Reliability was not degraded substantially until bandwidth dropped below 2.5 kHz. The statistical reliability and efficiency of the test suit it to practical applications in which measures of speech intelligibility are required.

To develop and evaluate a shortened version of the Profile of Hearing Aid Benefit, to be called the Abbreviated Profile of Hearing Aid Benefit, or APHAB. The Profile of Hearing Aid Benefit (PHAB) is a 66-item self-assessment, disability-based inventory that can be used to document the outcome of a hearing aid fitting, to compare several fittings, or to evaluate the same fitting over time. Data from 128 completed PHABs were used to select items for the Abbreviated PHAB. All subjects were elderly hearing-impaired who wore conventional analog hearing aids. Statistics of score distributions and psychometric properties of each of the APHAB subscales were determined. Data from 27 similar subjects were used to examine the test-retest properties of the instrument. Finally, equal-percentile profiles were generated for unaided, aided and benefit scores obtained from successful wearers of linear hearing aids. The APHAB uses a subset of 24 of the 66 items from the PHAB, scored in four 6-item subscales. Three of the subscales, Ease of Communication, Reverberation, and Background Noise address speech understanding in various everyday environments. The fourth subscale, Aversiveness of Sounds, quantifies negative reactions to environmental sounds. The APHAB typically requires 10 minutes or less to complete, and it produces scores for unaided and aided performance as well as hearing aid benefit. Test-retest correlation coefficients were found to be moderate to high and similar to those reported in the literature for other scales of similar content and length. Critical differences for each subscale taken individually were judged to be fairly large, however, smaller differences between two tests from the same individual can be significant if the three speech communication subscales are considered jointly. The APHAB is a potentially valuable clinical instrument. It can be useful for quantifying the disability associated with a hearing loss and the reduction of disability that is achieved with a hearing aid.

The Glasgow Benefit Inventory (GBI) is a measure of patient benefit developed especially for otorhinolaryngological (ORL) interventions. Patient benefit is the change in health status resulting from health care intervention. The GBI was developed to be patient-oriented, to be maximally sensitive to ORL interventions, and to provide a common metric to compare benefit across different interventions. The GBI is an 18-item, postintervention questionnaire intended to be given to patients to fill in at home or in the outpatient clinic. In the first part of the paper, five different ORL interventions were retrospectively studied: middle ear surgery to improve hearing, provision of a cochlear implant, middle ear surgery to eradicate ear activity, rhinoplasty, and tonsillectomy. A criterion that was specific to the intervention was selected for each study, so that the patient outcome could be classified as above and below criterion. In all five interventions, the GBI was found to discriminate between above- and below-criterion outcomes. The second part of the paper reports on the results and implications of a factor analysis of patient responses. The factor structure was robust across the study, and so led to the construction of subscales. These subscales yield a profile score that provides information on the different types of patient benefit resulting from ORL interventions. The GBI is sensitive to the different ORL interventions, yet is sufficiently general to enable comparison between each pair of interventions. It provides a profile score, which enables further breakdown of results. As it provides a patient-oriented common metric, it is anticipated that the GBI will assist audit, research, and health policy planning.