Hearing AidStarkeyPMCFNCT07298499
Amplification and Tinnitus Masker Performance and Benefit for Adults With Hearing Loss and Tinnitus
A study testing Hearing Aid and Tinnitus Masker in people with Hearing Aid and Tinnitus, run by Starkey Laboratories, Inc at 1 site in United States.
Trial summary
This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Aid, Tinnitus
- What is being tested?
- Hearing Aid and Tinnitus Masker
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Native English speaking (defined that all education was done in English)
- Bilateral hearing impairment ranging from mild to profound
- Mild to severe tinnitus
- Ability to commute to research facility
Who cannot join
- Participants will be advised to consult promptly a doctor, preferably an ear specialist such as an ENT, prior to being fit with the study devices, if they display any of the following conditions:
- Visible deformity of the ear, either congenital or traumatic
- Fluid, pus, or blood coming out of the ear within the previous 6 months
- Pain or discomfort in the ear
- History of excessive ear wax or suspicion that something is in the ear canal
- Dizziness, either recent or long-standing
Show all 14Show fewer
- Sudden, quickly worsening, or fluctuating hearing loss within the previous 6 months
- Hearing loss or ringing (tinnitus) only in one ear or a noticeable difference in hearing between ears
- Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, and 2000 Hz
- Cognitive impairment
- Tinnitus with a somatic origin indicating a need for medical treatment
- Current user of noise masker delivered via a wearable device
- Hyperacusis or extreme sensitivity to sounds
- Is employed by the study sponsor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Starkey Satellite Research Facility Affordable Hearing Centers 6821 W 120th Ave Ste 2H, Broomfield, CO 80020
Broomfield, Colorado, 80020
About this study
Official title: Post-Market Clinical Follow-Up of Hearing Aids and Tinnitus Masker Technology
This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study:
The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions.
Read more
The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions.
Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.
Read the detailed description
The purpose of this study is to evaluate hearing aid amplification and tinnitus masker performance, and clinical benefit for adults with hearing loss and tinnitus. The participants of the study will include approximately 100 adults with bilateral hearing loss ranging from mild to profound and mild to severe tinnitus as determined by the Tinnitus Handicap Inventory.
Participants will be fit with hearing aids by a licensed research audiologist. Hearing aid fittings will be verified using real-ear measurements and performance will be evaluated by the response accuracy compared to hearing aid prescriptive targets. Participants will first be fit with only amplification for 3 months. The participants will wear the hearing aids regularly in the field and return to the research facility at several intervals to complete measures of hearing aid performance and listening tasks.
At the three-month mark, a tinnitus masker will be turned on through the participant's hearing aids. The masker will be adjusted to participant preferences for sound quality and masker output will be captured using real-ear measurements. The participants will then wear the hearing aids with a tinnitus masker enabled for 3 months and return to the research facility at several intervals to complete measures of hearing aid performance and listening perception tasks.
Through this study the following hypotheses will be tested:
The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions.
The use of well-fit amplification in conjunction with an ear-level tinnitus masker improves participants' ability to hear and improves tinnitus symptoms.
According to the American Speech, Language, and Hearing Association, "fitting and monitoring the use of tinnitus maskers, hearing aids, or other ear-level sound generators" are all acceptable management techniques for tinnitus. However, there is not guidance on the order of management strategies. In the ASHA guidance and peer-reviewed literature, there is no evidence of patient characteristics that indicate the patient will benefit from one intervention over another. There is previous research that indicates well- fit hearing aids providing amplification alone improves tinnitus symptoms in individuals with hearing loss and tinnitus. Widely accepted tinnitus management programs -- Tinnitus Retraining Therapy, Progressive Tinnitus Management, and Tinnitus Activities Treatment-- recommend the use of tinnitus masking devices in addition to amplification as a component of tinnitus management for individuals with hearing loss and tinnitus . In randomized controlled studies, it has been found that participants with tinnitus showed equal improvement with tinnitus symptoms when fit with amplification only and when fit with amplification and sound masker devices when compared to no intervention. These studies indicate improvement in tinnitus with intervention versus no intervention. The present study will continue this line of research with participants wearing hearing aids with amplification alone and hearing aids with amplification and a tinnitus masker.
For this study, all participants will first be fit with hearing aids providing amplification only for 3 months and then the tinnitus masker will be enabled in the hearing aids for the second half of the study. This study design was chosen due to the inability to blind the participant or researcher from the intervention and because it mimics many patients' experiences with clinical protocols. The study design also reduces the potential ethical concern of providing the tinnitus masker and removing it as the researchers may be withholding an effective tinnitus management tool after the participant has already grown accustomed to it. When the tinnitus masker is enabled at the 3-month mark, the participants will continue to have access to an amplification only program they can navigate to with their hearing aids. The participants will be encouraged to remain in the tinnitus masker program as much as possible.
The study hypotheses will be tested by comparing clinical benefit questionnaires against normative data or quantifying minimal clinically important differences from unaided to aided conditions for individual participants. Performance of amplification and tinnitus maskers will be verified using real-ear measurements and will confirm the safety of the hearing aids and tinnitus maskers by following the participants for 6 months.
- Conditions
- Hearing Aid, Tinnitus
- Being tested
- Hearing Aid, Tinnitus Masker
- Keywords
- hearing aid benefit
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing AidDevice
Inclusion of hearing aid or not for listening
Tinnitus MaskerDevice
Inclusion of tinnitus masker in device
| Study group | Role | What they receive |
|---|---|---|
| Amplification with or without masker | Experimental | Amplification alone or amplification plus tinnitus masker Receives: Device: Hearing Aid; Device: Tinnitus Masker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provision of adequate amplification
Real-ear measures (level of sound at various frequencies measured at the tympanic membrane) will be used to show the hearing aid is providing adequate amplification to compensate for the hearing loss in agreement with a prescriptive fitting formula. The hearing aid responses were measured, and target matched using the Audioscan Verifit system with the ISTS stimuli at various presentation levels (50, 65, and 80 dB SPL). The clinical standard expects measured levels to fall within 5 dB of prescriptive gain targets at 500, 1000, and 2000 Hz, and 8 dB of prescriptive gain targets for 3000 and 4000 Hz.
Measured: The time frame of this data collection is at the hearing aid fitting which occurs at the initial fitting (Session 1, day 1). This will occur the first time the participant is seen for the study visits.
Device Oriented Subjective Outcome (DOSO) questionnaire to evaluate perceived benefit
The Device Oriented Subjective Outcome (DOSO) Scale is used to determine the effectiveness of hearing aids in various situations. This questionnaire is answered by the participant in reflection of their experience with hearing aids. Responses to the questionnaire are based upon the participant's perception of their experience with the hearing aids. The DOSO score is numerical and a higher number corresponds to higher satisfaction between 1 and 7.
Measured: The time frame of this data collection will occur at session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire is a widely used measure of hearing aid benefit in a variety of real-life situations. The APHAB is a self-report questionnaire that relies on the participant's perception of their experiences both without hearing aids and after being fit with hearing aids. Scores are numeric between 0 and 100, and difference in score between unaided and aided shows how much of a change is associated with the amplification. Positive numbers mean the amplification provides benefit, while negative numbers mean the amplification is degrading performance.
Measured: The time frame of this data collection will occur at session 1(initial fitting, day 1), session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)
Tinnitus Handicap Inventory (THI) questionnaire
The Tinnitus Handicap Inventory is a widely used questionnaire to understand the impact of tinnitus on someone's daily life. A numeric score is generated between 0 and 100, and the higher the number, the more handicap is generated by the Tinnitus. A change in score between unaided and aided would show either an increase in handicap or decrease in handicap between unaided and aided conditions.
Measured: The time frame of this data collection will occur at session 1 (initial fitting, day 1), session 4 (12 weeks), and session 7 (24 weeks)
Tinnitus Functional Index (TFI) questionnaire
The Tinnitus Functional Index is a widely used questionnaire to understand the multiple domains of tinnitus severity. The outcome is a numeric value between 0 and 100 corresponding to how well the listener can function in various listening situations. The higher number corresponds to increased difficulty functioning, and comparison between unaided and aided conditions determines how much the aided condition improves functioning.
Measured: This data will be collected at Session 1(day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks), Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks).
Monitoring of Treatment-Related Adverse Events as Assessed by Otoscopy
Otoscopy and visual inspection will be conducted at each laboratory visit to examine the structures of the ear that come in contact with the hearing aid, namely the outer ear and the external auditory canal, to look for signs of rubbing, abrasion, or skin reactions which should not occur. Adverse events such as these skin changes or reactions associated with the use of the hearing aids, observed in the study will be reviewed, recorded, and treated according to recommended treatment guidelines to confirm that the devices are not negatively causing soreness or irritation and that the benefits from the devices with respect to hearing and tinnitus outweigh the risks.
Measured: This data will be collected at Session 1(day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks), Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start7 Jul 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Hearing AidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participants will have seven lab sessions and six field trials. In the first session, every participant will be fitted with commercially available, post-market prescription hearing aids. Participants will have follow-up sessions after two, six, twelve, eighteen, and twenty-four weeks. The primary safety outcome measure will be gathered at each session. The primary performance outcome measure will be gathered at the initial session. The primary benefit outcome measures pertaining to the benefit of amplification will be gathered at baseline, at twelve weeks, and at twenty-four weeks, and the primary benefit outcome measures pertaining to tinnitus outcomes will be gathered at each session. At the twelve-week session, participants will be fitted with a tinnitus masker using the same commercially available, post-market prescription hearing aids.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starkey Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Hicks, Ph.D., Principal investigator, VP Education and Audiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298499
- Sponsor's protocol ID
- StarkeyPMCF2025
- Other IDs
- PMCF2025
- Acronym
- StarkeyPMCF
- Status last verified
- Dec 2025
- First submitted
- 5 Feb 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Tinnitus Retraining Therapy Trial Research Group; Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jul 1;145(7):597-608. doi: 10.1001/jamaoto.2019.0821.
PubMed 31120533Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
PubMed 8630207Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.
PubMed 22156949Jastreboff PJ, Jastreboff MM. Tinnitus Retraining Therapy (TRT) as a method for treatment of tinnitus and hyperacusis patients. J Am Acad Audiol. 2000 Mar;11(3):162-77.
PubMed 10755812Beck JE, Zaugg TL, Egge JL, Lima EN, Thielman EJ. Progressive Tinnitus Management at Two Veterans Affairs Medical Centers: Clinical Implementation With Modified Protocols. Am J Audiol. 2019 Apr 22;28(1S):162-173. doi: 10.1044/2018_AJA-TTR17-18-0040.
PubMed 31022363Myers PJ, Griest S, Kaelin C, Legro MW, Schmidt CJ, Zaugg TL, Henry JA. Development of a progressive audiologic tinnitus management program for Veterans with tinnitus. J Rehabil Res Dev. 2014;51(4):609-22. doi: 10.1682/JRRD.2013.08.0189.
PubMed 25144174Jastreboff PJ. Tinnitus retraining therapy. Prog Brain Res. 2007;166:415-23. doi: 10.1016/S0079-6123(07)66040-3.
PubMed 17956806Del Bo L, Ambrosetti U. Hearing aids for the treatment of tinnitus. Prog Brain Res. 2007;166:341-5. doi: 10.1016/S0079-6123(07)66032-4.
PubMed 17956798Cox RM, Alexander GC, Xu J. Development of the Device-Oriented Subjective Outcome (DOSO) scale. J Am Acad Audiol. 2014 Sep;25(8):727-36. doi: 10.3766/jaaa.25.8.3.
PubMed 25380119Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
PubMed 7789669Preferred Practice Patterns for the professions of speech-language pathology and audiology. American Speech-Language-Hearing Association. ASHA Suppl. 1993 Mar;35(3 Suppl 11):i-viii, 1-102. No abstract available.
PubMed 8097652
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-Up of Hearing Aids and Tinnitus Masker Technology
- ClinicalTrials.gov ID
- NCT07298499
- Acronym / sponsor ID
- StarkeyPMCF / StarkeyPMCF2025
- Conditions
- Hearing Aid, Tinnitus
- Keywords
- hearing aid benefit
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Starkey Laboratories, IncIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Post-Market Clinical Investigation whose primary purpose is to evaluate hearing aid amplification and tinnitus masker performance for individuals with hearing loss and tinnitus. There are two primary hypotheses that will be assessed in this study:
The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions.
The use of well-fit amplification in conjunction with a tinnitus masker improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions.
Participants will be fit with hearing aids for 6 months and a tinnitus masker will be activated at the 3-month mark of the study. Outcome measures will evaluate device performance and participant benefit from the devices throughout the study duration.
Detailed description
The purpose of this study is to evaluate hearing aid amplification and tinnitus masker performance, and clinical benefit for adults with hearing loss and tinnitus. The participants of the study will include approximately 100 adults with bilateral hearing loss ranging from mild to profound and mild to severe tinnitus as determined by the Tinnitus Handicap Inventory.
Participants will be fit with hearing aids by a licensed research audiologist. Hearing aid fittings will be verified using real-ear measurements and performance will be evaluated by the response accuracy compared to hearing aid prescriptive targets. Participants will first be fit with only amplification for 3 months. The participants will wear the hearing aids regularly in the field and return to the research facility at several intervals to complete measures of hearing aid performance and listening tasks.
At the three-month mark, a tinnitus masker will be turned on through the participant's hearing aids. The masker will be adjusted to participant preferences for sound quality and masker output will be captured using real-ear measurements. The participants will then wear the hearing aids with a tinnitus masker enabled for 3 months and return to the research facility at several intervals to complete measures of hearing aid performance and listening perception tasks.
Through this study the following hypotheses will be tested:
The use of well-fit amplification alone improves participants' ability to hear and improves tinnitus symptoms as compared to unaided conditions.
The use of well-fit amplification in conjunction with an ear-level tinnitus masker improves participants' ability to hear and improves tinnitus symptoms.
According to the American Speech, Language, and Hearing Association, "fitting and monitoring the use of tinnitus maskers, hearing aids, or other ear-level sound generators" are all acceptable management techniques for tinnitus. However, there is not guidance on the order of management strategies. In the ASHA guidance and peer-reviewed literature, there is no evidence of patient characteristics that indicate the patient will benefit from one intervention over another. There is previous research that indicates well- fit hearing aids providing amplification alone improves tinnitus symptoms in individuals with hearing loss and tinnitus. Widely accepted tinnitus management programs -- Tinnitus Retraining Therapy, Progressive Tinnitus Management, and Tinnitus Activities Treatment-- recommend the use of tinnitus masking devices in addition to amplification as a component of tinnitus management for individuals with hearing loss and tinnitus . In randomized controlled studies, it has been found that participants with tinnitus showed equal improvement with tinnitus symptoms when fit with amplification only and when fit with amplification and sound masker devices when compared to no intervention. These studies indicate improvement in tinnitus with intervention versus no intervention. The present study will continue this line of research with participants wearing hearing aids with amplification alone and hearing aids with amplification and a tinnitus masker.
For this study, all participants will first be fit with hearing aids providing amplification only for 3 months and then the tinnitus masker will be enabled in the hearing aids for the second half of the study. This study design was chosen due to the inability to blind the participant or researcher from the intervention and because it mimics many patients' experiences with clinical protocols. The study design also reduces the potential ethical concern of providing the tinnitus masker and removing it as the researchers may be withholding an effective tinnitus management tool after the participant has already grown accustomed to it. When the tinnitus masker is enabled at the 3-month mark, the participants will continue to have access to an amplification only program they can navigate to with their hearing aids. The participants will be encouraged to remain in the tinnitus masker program as much as possible.
The study hypotheses will be tested by comparing clinical benefit questionnaires against normative data or quantifying minimal clinically important differences from unaided to aided conditions for individual participants. Performance of amplification and tinnitus maskers will be verified using real-ear measurements and will confirm the safety of the hearing aids and tinnitus maskers by following the participants for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will have seven lab sessions and six field trials. In the first session, every participant will be fitted with commercially available, post-market prescription hearing aids. Participants will have follow-up sessions after two, six, twelve, eighteen, and twenty-four weeks. The primary safety outcome measure will be gathered at each session. The primary performance outcome measure will be gathered at the initial session. The primary benefit outcome measures pertaining to the benefit of amplification will be gathered at baseline, at twelve weeks, and at twenty-four weeks, and the primary benefit outcome measures pertaining to tinnitus outcomes will be gathered at each session. At the twelve-week session, participants will be fitted with a tinnitus masker using the same commercially available, post-market prescription hearing aids.
| Arm | Type | Receives |
|---|---|---|
| Amplification with or without masker | Experimental | Device: Hearing Aid, Device: Tinnitus MaskerAmplification alone or amplification plus tinnitus masker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Native English speaking (defined that all education was done in English)
- Bilateral hearing impairment ranging from mild to profound
- Mild to severe tinnitus
- Ability to commute to research facility
Key exclusion criteria (14 listed)
- Participants will be advised to consult promptly a doctor, preferably an ear specialist such as an ENT, prior to being fit with the study devices, if they display any of the following conditions:
- Visible deformity of the ear, either congenital or traumatic
- Fluid, pus, or blood coming out of the ear within the previous 6 months
- Pain or discomfort in the ear
- History of excessive ear wax or suspicion that something is in the ear canal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing AidInclusion of hearing aid or not for listening | Device | Amplification with or without masker |
| Tinnitus MaskerInclusion of tinnitus masker in device | Device | Amplification with or without masker |
Primary outcome
Provision of adequate amplification
Time frame: The time frame of this data collection is at the hearing aid fitting which occurs at the initial fitting (Session 1, day 1). This will occur the first time the participant is seen for the study visits.
Real-ear measures (level of sound at various frequencies measured at the tympanic membrane) will be used to show the hearing aid is providing adequate amplification to compensate for the hearing loss in agreement with a prescriptive fitting formula. The hearing aid responses were measured, and target matched using the Audioscan Verifit system with the ISTS stimuli at various presentation levels (50, 65, and 80 dB SPL). The clinical standard expects measured levels to fall within 5 dB of prescriptive gain targets at 500, 1000, and 2000 Hz, and 8 dB of prescriptive gain targets for 3000 and 4000 Hz.
Device Oriented Subjective Outcome (DOSO) questionnaire to evaluate perceived benefit
Time frame: The time frame of this data collection will occur at session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)
The Device Oriented Subjective Outcome (DOSO) Scale is used to determine the effectiveness of hearing aids in various situations. This questionnaire is answered by the participant in reflection of their experience with hearing aids. Responses to the questionnaire are based upon the participant's perception of their experience with the hearing aids. The DOSO score is numerical and a higher number corresponds to higher satisfaction between 1 and 7.
Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire
Time frame: The time frame of this data collection will occur at session 1(initial fitting, day 1), session 3 (6 weeks), session 4 (12 weeks), and session 7 (24 weeks)
The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire is a widely used measure of hearing aid benefit in a variety of real-life situations. The APHAB is a self-report questionnaire that relies on the participant's perception of their experiences both without hearing aids and after being fit with hearing aids. Scores are numeric between 0 and 100, and difference in score between unaided and aided shows how much of a change is associated with the amplification. Positive numbers mean the amplification provides benefit, while negative numbers mean the amplification is degrading performance.
Tinnitus Handicap Inventory (THI) questionnaire
Time frame: The time frame of this data collection will occur at session 1 (initial fitting, day 1), session 4 (12 weeks), and session 7 (24 weeks)
The Tinnitus Handicap Inventory is a widely used questionnaire to understand the impact of tinnitus on someone's daily life. A numeric score is generated between 0 and 100, and the higher the number, the more handicap is generated by the Tinnitus. A change in score between unaided and aided would show either an increase in handicap or decrease in handicap between unaided and aided conditions.
Tinnitus Functional Index (TFI) questionnaire
Time frame: This data will be collected at Session 1(day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks), Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks).
The Tinnitus Functional Index is a widely used questionnaire to understand the multiple domains of tinnitus severity. The outcome is a numeric value between 0 and 100 corresponding to how well the listener can function in various listening situations. The higher number corresponds to increased difficulty functioning, and comparison between unaided and aided conditions determines how much the aided condition improves functioning.
Monitoring of Treatment-Related Adverse Events as Assessed by Otoscopy
Time frame: This data will be collected at Session 1(day 1), Session 2 (2 weeks), Session 3 (6 weeks), Session 4 (12 weeks), Session 5 (14 weeks), Session 6 (18 weeks), Session 7 (24 weeks).
Otoscopy and visual inspection will be conducted at each laboratory visit to examine the structures of the ear that come in contact with the hearing aid, namely the outer ear and the external auditory canal, to look for signs of rubbing, abrasion, or skin reactions which should not occur. Adverse events such as these skin changes or reactions associated with the use of the hearing aids, observed in the study will be reviewed, recorded, and treated according to recommended treatment guidelines to confirm that the devices are not negatively causing soreness or irritation and that the benefits from the devices with respect to hearing and tinnitus outweigh the risks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Background: PubMed 31120533Tinnitus Retraining Therapy Trial Research Group; Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jul 1;145(7):597-608. doi: 10.1001/jamaoto.2019.0821.
- Background: PubMed 8630207Newman CW, Jacobson GP, Spitzer JB. Development of the Tinnitus Handicap Inventory. Arch Otolaryngol Head Neck Surg. 1996 Feb;122(2):143-8. doi: 10.1001/archotol.1996.01890140029007.
- Background: PubMed 22156949Meikle MB, Henry JA, Griest SE, Stewart BJ, Abrams HB, McArdle R, Myers PJ, Newman CW, Sandridge S, Turk DC, Folmer RL, Frederick EJ, House JW, Jacobson GP, Kinney SE, Martin WH, Nagler SM, Reich GE, Searchfield G, Sweetow R, Vernon JA. The tinnitus functional index: development of a new clinical measure for chronic, intrusive tinnitus. Ear Hear. 2012 Mar-Apr;33(2):153-76. doi: 10.1097/AUD.0b013e31822f67c0.
- Background: PubMed 10755812Jastreboff PJ, Jastreboff MM. Tinnitus Retraining Therapy (TRT) as a method for treatment of tinnitus and hyperacusis patients. J Am Acad Audiol. 2000 Mar;11(3):162-77.
- Background: PubMed 31022363Beck JE, Zaugg TL, Egge JL, Lima EN, Thielman EJ. Progressive Tinnitus Management at Two Veterans Affairs Medical Centers: Clinical Implementation With Modified Protocols. Am J Audiol. 2019 Apr 22;28(1S):162-173. doi: 10.1044/2018_AJA-TTR17-18-0040.
- Background: PubMed 25144174Myers PJ, Griest S, Kaelin C, Legro MW, Schmidt CJ, Zaugg TL, Henry JA. Development of a progressive audiologic tinnitus management program for Veterans with tinnitus. J Rehabil Res Dev. 2014;51(4):609-22. doi: 10.1682/JRRD.2013.08.0189.
- Background: PubMed 17956806Jastreboff PJ. Tinnitus retraining therapy. Prog Brain Res. 2007;166:415-23. doi: 10.1016/S0079-6123(07)66040-3.
- Background: PubMed 17956798Del Bo L, Ambrosetti U. Hearing aids for the treatment of tinnitus. Prog Brain Res. 2007;166:341-5. doi: 10.1016/S0079-6123(07)66032-4.
- Background: PubMed 25380119Cox RM, Alexander GC, Xu J. Development of the Device-Oriented Subjective Outcome (DOSO) scale. J Am Acad Audiol. 2014 Sep;25(8):727-36. doi: 10.3766/jaaa.25.8.3.
- Background: PubMed 7789669Cox RM, Alexander GC. The abbreviated profile of hearing aid benefit. Ear Hear. 1995 Apr;16(2):176-86. doi: 10.1097/00003446-199504000-00005.
- Background: PubMed 8097652Preferred Practice Patterns for the professions of speech-language pathology and audiology. American Speech-Language-Hearing Association. ASHA Suppl. 1993 Mar;35(3 Suppl 11):i-viii, 1-102. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Hearing Aid
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Not yet recruitingObservational study
New Hearing Aid Users and Their Social Participation
Hearing Loss, Hearing Aids
Recruiting
Barriers and Facilitators to OTC Hearing Aids Success
Hearing Loss, Sensorineural, Presbycusis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Hicks, Ph.D. principal investigator
VP Education and Audiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid and Tinnitus Masker in people with Hearing Aid and Tinnitus, run by Starkey Laboratories, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provision of adequate amplification (time frame: The time frame of this data collection is at the hearing aid fitting which occurs at the initial fitting (Session 1, day 1). This will occur the first time the participant is seen for the study visits.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07298499, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.