Pilot Study to Evaluate the Long-term Chronic Care of Patients Who Could or do Utilize an Osseointegrated Device (OID)

Change from baseline to month 36 on Ensuring Speech Understanding Test scores, evaluating a participants ability to hear the examiner during the Neurocognitive Test Battery

In this test, five sentences are read aloud to the participant by a research staff member, and the participant is asked to repeat back the sentence. Participants are scored on the number of target words repeated back correctly (3 target words/sentence). This test contains 2 trials, Trial 1 and Trial 2, with Trial 2 only being completed if the score on Trial 1 is below the specified criteria. The total score for Trail 1 is 1 (one target word repeated correctly) to 15 (all target words repeated correctly). If a participant's score is 12 or less on Trial 1, Trial 2 will be administered using a slightly louder tone. Trial 2 contains 15 target words and the same scoring criteria as Trail 1. If the score on Trial 2 is 12 or less, the examiner will use a slightly louder tone while administering the neurocognitive test battery. This test guards against poor speech understanding from hearing loss directly confounding administration of neurocognitive tests with auditory stimuli.

Change from baseline to month 36 on Mini Mental State Exam scores, evaluating cognitive function ability

This test is a standardized instrument for screening a limited number of cognitive functions. The MMSE is used to exclude those with significant cognitive impairment at baseline, and as an outcome for tracking cognitive decline, and dementia. The MMSE is administered by interview and should be attempted in all participants. Scores range from 0 (no cognitive function questions answered correctly) to 30 (all cognitive function questions answered correctly).

Change from baseline to month 36 on Delayed Word Recall Test scores, evaluating verbal memory

The DWRT is a measure of verbal memory that requires the participant to recall a list of 10 common nouns following a short delay. The participant is presented with a stimulus card for each of the 10 words. The examiner reads each word aloud, and asks the participant to repeat the word and use it in a sentence. This procedure is repeated, providing two exposures to the words. Following an approximate 5-minute delay, during which the (non-verbal) digit symbol substitution test (DSST) is given, the participant is asked to recall as many words as possible. Scores range from 0 (no words recalled correctly) to 10 (all words recalled correctly).

Change from baseline to month 36 on Digit Symbol Substitution Test scores, evaluating psychomotor speed and sustained attention

The DSST is a measure of psychomotor speed and sustained attention and also serves as a nonverbal distractor task, interposed between learning and recall for the Delayed Word Recall Test (DWRT). The participant is asked to translate numbers (1-9) to symbols using a key provided at the top of the test form. The participant is provided with a pencil (without an eraser). Instructions are provided in a deliberate and slow pace. One point is given for each correctly drawn symbol completed within the 90-second time limit. Scores range from 0 (no symbols correctly drawn) to 93 (all symbols correctly drawn).

Change from baseline to month 36 on Oticon SSD Questionnaire (OSSDQ) ratings, evaluating why a patient wants to use OID hearing intervention

The OSSDQ was developed by Oticon Medical as a brief instrument to capture reasons why a patient with single sided deafness may want to use OID hearing intervention. The OSSDQ is a self-administered questionnaire.

Change from baseline to month 36 on Tinnitus Functional Index (TFI) ratings, evaluating the intrusiveness of tinnitus in a participant's everyday life

The Tinnitus Functional Index has eight subscales that address the intrusiveness of tinnitus, the sense of control the patient has, cognitive interference, sleep disturbance, auditory issues, relaxation issues, quality of life, and emotional distress. The subject will report (either directly onto the questionnaire in person, via web, or over the phone) answers to each of the 25 questions using a scale of 0 (tinnitus did not interfere) to 10 (tinnitus completely interfered).

Change from baseline to month 36 on Center for Epidemiological Studies Depression and Hopelessness Scale (CES-D) ratings, which screens for clinical depression

The CES-D Short Form is a screening tool for identifying clinical depression, and is a self-administered questionnaire. Participants are asked to rate each item on a 3-point scale, 0 (hardly ever or never) to 2 (much or most of the time), on the basis of "how often you have felt this way during the past week."

Change from baseline to month 36 on Baecke Physical Activity Questionnaire (BPAQ) ratings, evaluating the frequency and duration of self report activities

This is a self-administered questionnaire given to each participant that measures the frequency and duration of self-reported activities. This questionnaire asks about habitual physical activities including sport-related activities during leisure time, non-sport related physical activity during leisure time, and television viewing. Ratings range from A (least amount of physical activity) to E (highest amount of physical activity), with each question containing a different explanation for scores A-E based on the question asked.

Change from baseline to month 36 on the Audiometric Assessment, evaluating pure tone and speech audiometric abilities

The audiometric diagnostic battery will be conducted by a trained audiology staff member for all participants. This assessment is standard of care. The battery includes otoscopy, tympanometry, pure tone audiometry, and speech audiometry (including word recognition testing in noise). The goal of this battery it to provide a diagnosis of hearing loss at the screening appointment, and then to monitor the participants hearing status during the study's time period.