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

OTHER

No intervention

This is an observational study of participants that either choose or not choose to utilize an OID. This is not an intervention prescribed study, however, participants may choose uptake of standard of care intervention and obtain and utilize an OID. An OID is an FDA-approved device commonly recommended to patients with conductive, mixed, or singled-sided hearing loss. There is no experimental intervention evaluated in this study.

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

Time frame: Baseline and Month 36

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

Time frame: Baseline and Month 36

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

Time frame: Baseline and Month 36

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

Time frame: Baseline and Month 36

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 Incidental Learning Test scores, evaluating non-verbal recent memory

Time frame: Baseline and Month 36

The Incidental Learning Test was adapted from the WAIS-R NI and provides a non-verbal measure of recent memory. Following the Digit Symbol Substitution Test (DSST), the participant is presented with the Incidental Learning Template. The participant is asked to write down as many of the DSST symbols as he/she can remember, in any order. Next, the participant is asked to write down the number that was paired with each of the symbols from the DSST. Two scores are yielded: 1) Free Recall: total number of symbols recalled, regardless of pairing and 2) Pairing: number of correct symbols correctly paired with corresponding numbers. Scores for each range from 0 (no symbols recalled, no symbols correctly paired to corresponding numbers) to 9 (all symbols recalled, all symbols correctly paired to corresponding numbers).

Change from baseline to month 36 on Trail Making Test Part A (TMT A) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function

Time frame: Baseline and Month 36

The TMT A is a timed task in which participants connect numbers in sequence as quickly as possible. TMT measures attention, sequencing, mental flexibility, and visual search and motor function. In the TMT A, the participant is asked to draw a line and connect a series of numbers (from 1-25) as quickly as possible. Prior to the test part, the participant is given a sample test to demonstrate the task. The score for TMT A is the number of seconds required to complete the task. Scores range from 1 (1 second to connect all numbers) to 240 (240 seconds to connect all numbers). A maximum of 240 seconds (4 minutes) and 5 errors is allowed. If a participant makes 5 errors, the test is stopped even if the participant has not reached the 240 second limit, and a score of 240 seconds is given.

Change from baseline to month 36 on Trail Making Test Part B (TMT B) scores, evaluating attention, sequencing, mental flexibility, visual search, and motor function

Time frame: Baseline and Month 36

The TMT Part B is a timed task in which participants connect letters and numbers in sequence as quickly as possible. The TMT measures attention, sequencing, mental flexibility, and visual search and motor function. In the TMT B, the participant is asked to draw a line and connect a series of numbers and letters, alternating between a given number and letter (e.g., 1 to A, A to 2, 2 to B, B to 3, etc.) as quickly as possible. Prior to the test part, the participant is given a sample test to demonstrate the task. The score for TMT B is the number of seconds required to complete the task. Scores range from 1 (1 second to connect all numbers and letters) to 240 (240 seconds to connect all numbers and letters). A maximum of 240 seconds (4 minutes) and 5 errors is allowed. If a participant makes 5 errors, the test is stopped even if the participant has not reached the 240 second limit, and a score of 240 seconds is given.

Change from baseline to month 36 on Logical Memory I and II scores, evaluating immediate and delayed verbal recall

Time frame: Baseline to Month 36

The Logical Memory I and II provides a measure of immediate and delayed verbal recall for the number of ideas presented in two stories, which are read to the participant. Both stories are read to the participant, and after each story is presented, the participant is asked to recall as much of the story as possible. The Logical Memory I score is calculated as the average number of ideas recalled from Story A and B. Each story contains 25 scoring units, the maximum score is 25 (25+25/2). An approximate 20-minute delay follows, during which the remaining (non-memory) tests are administered. Following the delay period, the participant is again asked to recall the stories. The Logical Memory II score is calculated as the average number of story elements recalled from Story A and B. Scores range from 0 (no story elements correctly recalled) to 25 (all story elements correctly recalled).

Change from baseline to month 36 on Digit Span Backwards scores, evaluating attention and working memory

Time frame: Baseline to Month 36

The Digit Span Backwards is part of the Wechsler Memory Scale-Revised and provides a measure of attention and working memory. The participant is read a series of numbers progressively increasing in length from two to eight digits. After the numbers are read, the participant is asked to repeat the numbers in the reverse order. Two trials at each digit length are performed (i.e., 2 trials with 2 digits, 2 trials with 3 digits, etc.). The test is discontinued after two consecutive errors of the same length item. Scores range from 0 (no trails correctly repeated in reverse order) to 12 (all trials correctly repeated in reverse order).

Change from baseline to month 36 on Boston Naming Test scores, evaluating visual naming ability

Time frame: Baseline to Month 36

The Boston Naming Test assess visual naming ability using black-and-white drawings of common objects. For this study, the 30-item version used by the National Alzheimer's Coordinating Centers Uniform Data Set will be used. The participant is presented with a series of line drawings of objects and asked to name each object. The items become progressive more difficult based on their frequency of occurrence in the English language. A total score is calculated as the number of spontaneously produced correct responses. Scores may range from 0 (no object named correctly) to 30 (all objects named correctly).

Change from baseline to month 36 on Word Fluency Test scores, evaluating verbal functioning

Time frame: Baseline to Month 36

The Word Fluency Test is a measure of verbal functioning. In this task, the participant is asked to produce as many words as possible that begin with the letters F, A, and S within a time limit of 60 seconds for each letter, avoiding proper nouns, variations, plurals, and repetitions. The score is the total number of admissible words produced across letters, ranging from 0 (no words produced) to X (number of words produced).

Change from baseline to month 36 on Animal Naming Test scores, evaluating category fluency

Time frame: Baseline to Month 36

Animal Naming is a measure of category fluency (semantic association). Category fluency, and specifically animal naming, is part of the Boston Diagnostic Aphasia Examination, the Stanford-Binet test, and the CERAD. The participant is asked to name as many different animals as possible within a 60 second time limit. The score is given as the sum of all admissible names, from 0 (no animals named) to X (number of animals named).

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.